chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of Menveo only with the diluent portion (without the powder component) /  nurse did not reconstitute the liquid with the powder portion; patient received a dose of Menveo only with the diluent portion (without the powder component); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Menveo only with the diluent portion (without the powder component) the nurse did not reconstitute the liquid with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care practitioner did not have available patient's information. The reporter consent to follow up.
I was finally starting to recover from months of Long COVID, but the second vaccine reactivated my symptoms.  I?ve been sick and too tired to function for three weeks since I got the shot.
Severe headaches, body aches and flu-like symptoms, 5 days after, on 2/19/03 AM. Woke up with a really bad sore throat at 06:00. Also had fever/chills and arthralgias. 24 hours in quarters with Motrin and Tylenol. Dx'd with viral syndrome. Later that night, started feeling chest pain radiating to neck. Went back to ER and was admitted on 2/19/03. Treated with GI Cocktail with no results. Treated with 3 nitroglycerin tablets and with IV Morphine. Discharged on 2/24/03. Convalescent leave for 7 days and take Motrin and Aspirin. Viral myocarditis can also be caused by enteroviruses and adenoviruses to name a few; however, if he has myocarditis, it is almost certainly related to Smallpox vaccination given the temporal relation. We also considered coronary vasospasm, especially given the cardiologist's subjective assessment of decreased myocardial perfusion on the catheterization which can be associated with coronary vasospasm. However, it is my understanding that vasospasm causing this degree of damage in the absence of concomitant CAD is a very, very rare occurrence. Furthermore, the pt never had any other symptoms consistent with angina and I would have expected nitroglycerin to give him prompt relief in the setting of vasospasm. Therefore, given the concomitant viral symptoms due to Smallpox vaccination and the normal catheterization results, I feel this pt most likely has acute viral myocarditis presumedly due to vaccinia. Yet, myocarditis is a clinical dx and there is no way to definitively test this hypothesis (except by myocardial biopsy). We will be re-evaluating this pt today and tomorrow in our ICU to get more info, however, I doubt my assessment will change.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 02-JAN-2018 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA004525: US-009507513-1801USA005371: US-009507513-1801USA005372:
hives; Heartbeats increased; Swallowing difficult; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), HEART RATE INCREASED (Heartbeats increased) and DYSPHAGIA (Swallowing difficult) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (hives), HEART RATE INCREASED (Heartbeats increased) and DYSPHAGIA (Swallowing difficult). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, URTICARIA (hives), HEART RATE INCREASED (Heartbeats increased) and DYSPHAGIA (Swallowing difficult) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Patient got the 1 shot yesterday. Within 4 hours she had hives, a rapid heartbeat and difficulty swallowing. She wanted to know if she should get the second dose.
Left buttock; large area of erythema and induration around DTaP site. Also had blistering of skin and a small ulcerative type area at site of injection. Erythema spread rapidly despite oral antibiotics. CBC, Sed Rate, wound culture all negative. Thus, suspicion of localized reaction rather than cellulitis. Nonetheless, was treated with 2 days of IV antibiotics and sent home on oral course.  Nurse follow up on 09/13/04 states: "No new information."
Red,  circular rash on vaccination site. Left arm. Appeared 2nd day after vaccine was administered. This was was my 2nd shot. Did not happen with the 1st shot.
Patient presented to ED 9/10/21 and was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. COVID antigen test was positive 9/10/21. Patient was discharged to home 9/13/21.
red area, pain when touching, hot, mucus it was putting in passing the most large and painful days of 2 weeks.
Sore arm; fatigue; little tired; feeling achy; Covid arm; a rash that is warm ,red, and itchy; a rash that is warm ,red, and itchy; a rash that is warm ,red, and itchy; second dose on 4Mar2021 in my right arm which is a 34 days difference.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SKIN WARM (a rash that is warm ,red, and itchy), FATIGUE (fatigue), ERYTHEMA (a rash that is warm ,red, and itchy) and FATIGUE (little tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on 4Mar2021 in my right arm which is a 34 days difference.). On 09-Mar-2021, the patient experienced SKIN WARM (a rash that is warm ,red, and itchy), ERYTHEMA (a rash that is warm ,red, and itchy), COVID-19 (Covid arm) and PRURITUS (a rash that is warm ,red, and itchy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). an unknown date, the patient experienced FATIGUE (fatigue), FATIGUE (little tired) and PAIN (feeling achy). On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on 4Mar2021 in my right arm which is a 34 days difference.) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), SKIN WARM (a rash that is warm ,red, and itchy), FATIGUE (fatigue), ERYTHEMA (a rash that is warm ,red, and itchy), FATIGUE (little tired), PAIN (feeling achy), COVID-19 (Covid arm) and PRURITUS (a rash that is warm ,red, and itchy) outcome was unknown. Not Provided          No relevant concomitant medications provided. No relevant Treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.
Had numbness and tingling in hands , and pain feet.  Observed for 30 minutes given OJ. Departed on her own after reporting s/s resolved.
At 1800 developed headache, 2000 developed chills, temperature of 99.6 (normal daily T on this thermometer 96.8-97.5), slight nausea, dizziness with standing.  Excederin at 0000, sweating at 0100, T 98.2 at 0400.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042258, expiry date 18-AUG-2018) (strength, dosing details, anatomical location were unknown). The vaccine had been stored at 8.1 degree Celsius for 15 minutes, and also at 8.3 degree Celsius for 15 minutes. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
This is a spontaneous report from a contactable consumer or other non-health care professional, the patient. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no; not reported/Lot Number: ep6955) via an unspecified route of administration on 16Mar2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. The patient had no other medical history. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced with flushed face that began with first shot and was experiencing this daily at the time of report. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event flushed face that began with first shot and was experiencing this daily was not resolved at the time of this report.No follow-up attempts are needed. No further information is expected.
rash as local to injection site; red rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site rash, red rash and itchy rash. On an unknown date, the outcome of the injection site rash, red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced rash which was began approximately 3 to 4 days after dose and was still present. The rash was local to injection site on left deltoid, at least six inches in length, red, and itchy. The reporter consented to follow up. This case has been linked with case US2021201405, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201405:same reporter
nonspecific autoimmune; got hives if anything of weight touched my body; This case was reported by a consumer via media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the autoimmune disorder and hives were not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder and hives to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got only one dose of Shingrix and it threw him/her into nonspecific autoimmune where he/she got hives if anything of weight touch to the body of patient, like purse straps, bra straps, panty lines or the bottom of his/her feet against the shovel to dig. As per the the patient, Shingrix only prevents 40 percent.
Fully vaccinated with booster; Tested positive for COVid; Tested positive for COVid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Tested positive for COVid"; IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Fully vaccinated with booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: Tested positive for Covid.  Clinical course: Patient has tired, sniffles and sore throat. Event took place after use of product. .   The lot number for bnt162b2 was not provided and will be requested during follow up.
Shivers, aches and pains throughout body about 5-6 hrs after vaccination. Strong flu like symptoms (per patient statement) for about 3 days.
Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Patient presented to the clinic for her 2nd dose of HPV9. It was given 1 week too early.
loose stools; less severe rectal irritation and pain; less severe rectal irritation and pain; bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: ER8737) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "SIBO" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: tomatoes, chili peppers" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTONE; PREGNENOLONE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EN6208, lot unknown=False, administration date=15Mar2021, administration time=12:15 PM, vaccine location=Left arm, dose number=1), administration date: 15Mar2021, when the patient was 52 years old, for Covid-19 immunisation, reaction(s): "severe stomach pain", "cramping", "gas", "diarrhea", "headache", "bloating", "rectal irritation and pain", "rectal irritation and pain". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "loose stools"; PROCTALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "less severe rectal irritation and pain"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "bloating". Additional information: Symptoms lasted 24-36 hours after each injection. No follow-up attempts are possible. No further information is expected.
2 1/2 hrs post vax pt became very pale & listless; had episode of tremors of upper extremities; One episode of vomiting, listless for several hrs;
DAY 1 - SWELLING AND DSICOMFORT AT INJECTION SITE - USED ICE AND KEPT MOVING ARM A LITTLE NAUSEA AND "BLAH" FEELING LIKE AFTER FLU SHOT WHICH WAS EXPECTED AT THE END OF THE DAY NOTICED THAT MY KNEES AND LEGS WERE SWOLLEN WHICH ONLY HAPPENS WHEN I EAT SHELLFISH - THERE WAS NO OTHER PROBLEM - I KEPT MY LEGS ELEVATED AT NIGHT AND SWELLING WAS DOWN A LITTLE IN THE MORNING. DAY 2 CALLED PRIMARY CARE PHYSICIAN (PCP)- WE AGREED IT WAS OK TO TAKE BENADRYL AND IF DIDN'T CLEAR UP I WOULD NEED TO GO INTO HIS OFFICE FOR EVALUATION. BENADRYL STARTED WORKING AFTERNOON OF DAY 2. ALL SWELLING DOWN ON AFTERNOON OF DAY 4 (SATURDAY 3/20). REPORTED BACK TO PCP ON DAY 6 (MONDAY 3/22).
On 12/4/09, around 1400, service member received the Monovalent H1N1 Influenza vaccine in his right upper arm. He denies any symptom onset with the first 4 hours of vaccine receipt. Around 1915-1930 that evening, he began itching across his chest and abdomen. At first, he thought it was related to dry skin, but as itching continued and intensified, he examined the pruritic area and saw hives on his chest. Around the same time, he noted his "throat hurt" and he was "losing (his) voice". Around 2100, he went to the ED (No records of visit are currently available). He reports being given IV BENADRYL, IV steroids, another IV medication (ZANTAC?) and also a shot in his arm (?epinephrine). He said he was afebrile, but had broken out in sweat. He thinks his BP may have been elevated because he was upset. He had not GI-related symptoms at that time. He denies angioedema, dyspnea and wheezing. He was observed over-night and by 0515, the hives had resolved. his voice had improved significantly and the itching had decreased. He was discharged from the ED with a prescription of ZANTAC, BENADRYL, and 5-day course of steroids. Over the week-end, he "took it easy" and noted some mild itching of his arms and trunk during the day. He also noted that he was "extremely thirsty", he had a mild headache and aching back pain at the small of his back. He has taken TYENOL for his headache and lower back pain with relief of his headache and significant decrease of his back pain.
Patient made second appointment on line and chose pharmacy.  He reported to pharmacy window, stating he had an appointment, confirmed, but did not have his initial vaccination record card.  Pharmacy staff stated Moderna.  Pt did not imply differnet vaccine.  Not until verification of administration of vaccine did a report appear that Patient  previously received the Pfizer.  Patient notified via phone message on both land line and cell phone. Patient said he was fine .  Patient told not to revaccinate.
lost conscious; siziures; Extreme sweats; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 25Mar2021 at 11:30 at the age of (65-years-old at time of vaccination) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was did not diagnosed with covid-19. Since the vaccination, the patient was did not diagnosed with covid-19. It was reported that on an unspecified date in 2021 the patient experienced extreme sweats, lost conscious, seizures. The patient was not hospitalized due to these events. The patient did not receive any treatment for the events. The patient visited physician office due to these events. The outcome of the events was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a physician via call center representative and described the occurrence of hives in a 11-year-old female patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). Concomitant products included MENACTRA. On 4th August 2017, the patient received BOOSTRIX. On 5th August 2017, 1 days after receiving BOOSTRIX, the patient experienced hives. On 6th August 2017, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX in the left deltoid. On the same day, the patient received MENACTRA concomitantly. The patient came a day before reporting on 1st November 2017, for a doctor visit and the patient's mother stated that, the patient experienced hives on her abdominal wall after 24 hours receiving the vaccines. The patient recovered from hives after 24 hours. No additional information was provided.