chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm where the injection took place is still painful; Keeps me awake at night; It throbs and keeps me awake at night; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a month after receiving Shingrix, the patient experienced pain in arm, sleep disturbance and throbbing pain. On an unknown date, the outcome of the pain in arm, sleep disturbance and throbbing pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, sleep disturbance and throbbing pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and experienced pain in arm where the injection took place. It throbs and kept patient awake at night. The patient wanted to know when will pain stop. The patient was not sure about receiving 2nd dose.
Fever of 105.4 degrees F with accompanied eye ball rolling & limpness same day pt. received the vaccines: Dtap, HIB, IPV, PCV 13, Hep B, Influenza vaccine.
Right arm vaccination injection is red and painful for a patient who was receiving  Trumenba; Right arm vaccination injection is red and painful for a patient who was receiving  Trumenba; This is a spontaneous report based on the information reported to Pfizer by Agency, (Reference#: A202008864) via a non-contactable consumer. A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose in right arm for immunisation. Medical history and concomitant medications were not reported. An adverse event of right arm vaccination injection site was red and painful was reported for a patient who was receiving product meningococcal group b rlp2086. Outcome of the events was unknown.  No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
Pt is a 15-year-old male with past medical history of anxiety who was admitted to our cardiology floor for pericarditis in the setting of recent COVID-19 vaccination.  Per mother he received his second dose of the Pfizer COVID-19 vaccine on Thursday.  Initially following the vaccine, he had no reaction and was asymptomatic.  However on Saturday he began with palpitations and mild chest pain.  On Sunday he continued with palpitations and also states that he felt a warm flushed type sensation on occasion.  Today (Monday), troponin was relatively asymptomatic, however given his symptoms over the weekend he was seen by his pediatrician who then referred his family to the emergency room.  Of note, patient has been without fevers, fever vomiting, diarrhea, or rashes. Mother denies that patient has any other cardiac history.  He has never had an echocardiogram or EKG done previously. There is no significant cardiac family history.  No history of cardiac medications, only home meds include duloxetine 30mg BID and Buspirone 10mg BID. No congenital heart disease, no heart surgery done in infancy or childhood in the family, no history of pacemakers, no history of arrhythmia, and no history of sudden or on known cause of death, namely before the age of 50.  In the ED, vital signs were normal. There troponin was done which resulted at 615 ng/L and a proBNP was done which was 120 pg/mL.  CRP was also done which was 22.5 mg/L.  EKG was done which demonstrated normal sinus rhythm with mild left axis deviation (likely lead placement related), and no significant ST segment or PR segment changes.  Respiratory pathogen panel (PCR) was completed at their ER and was negative including COVID-19.  Chest x-ray was obtained which demonstrated normal heart size and mild infiltrate and/or subsegmental atelectatic changes in the right lower lobe.  No medication aside from Motrin was given.  Dr. was called from the ED and decision was made to transfer patient to our facility for further management in the setting of vaccine related myopericarditis.
vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S020961 with an expiration date on 07-JUL-2021) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperature excursión of -58 degrees Fahrenheit (°F) and +46°F (-50 Celsius degrees (°C) to +8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.    No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002064: US-009507513-2104USA002067:
Received flu vaccine 10/25/16 in (L) deltoid. Site was warm to touch, burning sensation, painful and had a raised red area where vaccine was given the size of a 50 cent piece-per patient. She came to clinic on 10/26 and informed us of this. She said she felt a little nauseated. On 10/27 she said she was much better the site not as red or warm and was down to 25 cent size. Used cool compresses.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, multiple patients were vaccinated with a dose of improperly stored (oral, ROTATEQ) lot# K024700, expiry date 30-JUL-2016, dose was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
temperature exposed; This spontaneous report was received from a physician referring to a 20 years old male patient. Information regarding the patient's medical history, concurrent condition and concomitant medication were not provided.  On 24-MAY-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T010311, expiration date 24-MAR-2022; strength and dose were unknown) was administered via subcutaneous route at the left arm for prophylaxis after temperature excursion (product storage error). A data logger was involved.
myocarditis. elevated troponin, ECG changes, good function on echo. treated with NSAIDs
Fatigue, aches systemically  Bruising, itchiness, red ring spreading at injection site
Persistent, recurrent "floaters" in visual field. Persistent every day for a week and then recurrent a few times a day until the date of this report.
4/28/2021-very sudden and rapid (within minutes) severe skin burning pain head to toe. Since that date, burning full body neuropathy has worsened. The last year has involved multiple specialists/testing and newly developed reactions/diagnoses. Continue to worsen despite testing/treatment attempts. Now struggle with malabsorption, mast cell activation syndrome, small fiber neuropathy, cardiac Vaso spasms, joint inflammation/pain, chronic fatigue.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 28-OCT-2012 03:47, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
REPORTED RED EARS - SHORTNESS OF BREATH - PATIENT IS RN - - WAS TREATED BY PHYSICIAN IN HER CLINIC - RECEIVED ANTIHISTAMINES & PREDNISONE - - AWAITING MORE DETATILS FROM PATIENT
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 09-NOV-2011, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Patient given adult dose of Moderna vaccine instead of pediatric. Monitored post administration ~20 minutes. No signs/symptoms noted.
Just noticed itching upper left arm rash this morning about 2 inches in diameter and adjacent to but not covering injection site.  No timeline yet.
Approximately 4 weeks after the J&J Vaccine I developed chronic hives and angiodema, including swelling of the limbs and face.   Hives show up everyday  since then and now has become a chronic issue. I have never had any health issues before this and was very healthy. This issue has been going for 3.5 months now and doctors cannot find the root cause.
No additional AE; Medical assistant reported VAQTA was administered after temperature excursion.; This spontaneous report has been received from other health professional concerning to a patient of an unknown age and gender.   The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 16-AUG-2023, the patient was vaccinated with the first dose of improperly stored of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, anatomical location vaccination scheme frequency and route of administration were not provided; lot number reported as "Y3ME2", with expiration date reported as 23-FEB-2025, however, upon internal validation, lot number "Y3ME2" does not match any company product as confirmed by lot verification team) for prophylaxis (product storage error).   The administered dose of the vaccine was stored at a temperature of 8.9 degrees Celsius (C) on 14-AUG-2023, with a time frame of 12 hours 20 minutes 0 seconds; and 9.4 degrees Celsius (C) on 28-AUG-2023, during a time frame of 8 hours 20 minutes 0 seconds. There was no previous temperature excursion reported for "both" at the time of the called.   Additionally, it was reported that the operator of the device was a healthcare provider. The "HCP" provided lot number that did not appear to be similar to other Merck vaccine lot numbers; confirmed with HCP multiple times that this was the correct lot number, and the product was a Merck branded vaccine.  No additional adverse events (AE) were reported.
Breakthrough case after full vaccination. C/O sinus issues/onset 7/23/2021
pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety.  Used interpreter. 140/92 HR 128 O2 sat 97 BS 196
Pt reached out to discuss concerns of of the second Moderna immunization.  Pt reported small localized cellulitis around injection site following first injection about a week following as well a high fever about 12 hours.   Pt premedicated at home with loratiadine and Tylenol.  Pt medicated with 12.5 mg Benadryl elixir prior to receiving second vaccination. 12:22 - pt reports feeling a little itchy - additional 12.5 mg Benadryl elixir provided. 12:35 - Pt reports feeling fine and is going to return to work for the afternoon.   Pt instructions given regarding return to the ED and signs and symptoms to watch for.  Pt verbalizes understanding states she will reach out for any additional concerns.
delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311023 and 2019SA311024 (same reporter)  This case involves a 63 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 2FEB98 & approx 4 days later pt devel a rash on arms & ankles & joint pain in both ankles;also pt exp a low grade fever of 101;blood work was done & the results are pending;pt was seen by MD dx serum sickness;
This patient was administered a Pfizer Covid-19 vaccine but it was latter discovered that the incorrect diluent was used upon mixing the vaccine. 1.8 ml of Sterile Water for injection was accidently used to reconstitute the vaccine instead of 0.9% Normal Saline.  The correct amount was used and pt was administered 0.3ml. Pharmacy clinical team, Pfizer and CDC were  contacted and it was determined that Sterile water for injection was not studied and thus they could not comment whether or not this vaccine would be effective. However no expected harm would have resulted and it was recommended to revaccinate. Was finally able to reach Patient on 9-10-21, who was advised of error and patient stated he was doing fine only had temporary headache and sore arm but both completely resolved without incident. Patient stated he would think about revaccination.  Again no adverse event occurred this is being reported as vaccine administration error.
Pt was walking towards waiting area.  Pt was falling to floor with nurse breaking her fall.  Pt placed on backside with head lifted.  Family at side.  Pt started displaying seziure activity.  Placed on left side with head guarded.  EMS was notified at this time.  V/s obtained with b/p 168/98 HR 80 98% O2.  Pt agreed to leave with EMS at this time. A/Ox3.  Left with family at her side.
CDC reports: 16 mo child developed T 104 & rash 2 days following DTP/OPV/MMR immunization, lasted 2 days
Did not receive 2nd dose of Vaccine 43 days of 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Vaccine 43 days of 1st dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Vaccine 43 days of 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Vaccine 43 days of 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: ER8736) and on 17May2021 as dose 2, single (Lot number: EW0168) at the age of 37 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT, start date: Jan2022, stop date: May2022; NYQUIL, start date: 04May2022, stop date: 05May2022; DAYQUIL, start date: 04May2022, stop date: 05May2022.Known allergies are none.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of suspected covid-19.Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 06May2022, Treatment stop date: 10May2022, Lot number: FY9909, Indication: Treatment of COVID-19.  Follow-up attempts completed. No further information expected.
Pediatric Pfizer vial was not diluted by accident resulting in patient receiving 20 mcg dose instead of 10 mcg dose. Patient's mother was informed. No serious adverse reactions to the vaccine occurred. Just the typical side effects such as fatigue and chills.
Right arm with pink area and puffiness approximately 12.5x10cm. Prescribed Benadryl every 6 hours for 24 hours.
Developed tachycardia and chest tightness after vaccination.  No shortness of breath, dizziness, nausea or rash.  Symptoms resolved without treatment in about 37 minutes.
Fever of 103.5 degrees, nausea, vomiting, severe joint pain, red, swollen injection site (baseball size), probable dehydration - only urinated 1 time in 24 hours
Swelling/pain at injection site, Next morning after vaccination had headache, achy, very fatigued, during the day headache worsed and developed a mild fever
no adverse event; HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23).    This case contains information for the 1st infant patient out of 3 patients (2 infants and 1 adult) described by the reporter.  No concomitant medications were reported.  Reporter wants to know if there was any stability information for this invalid dose and reporter states that the patients could had possibly been 2 infants and 1 adult impacted by this invalid dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706707, US-MODERNATX, INC.-MOD-2023-706711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: The recent follow-up contains no new information. On 31-Jan-2023: Live Significant Follow-up contains Product information and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706707:Master Case US-MODERNATX, INC.-MOD-2023-706711:Master Case
Pt. received PNEUMOVAX in clinic 12/5 Rt. arm when here for her annual visit. (Pt. has a history of Crohn's Disease). Pt. called clinic & returned on 12/7 for Rt. arm tenderness & expanding redness. Painful ROM. No fever or chills. Placed on BACTRIM x 7 days, compresses, TYLENOL
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received SHINGRIX for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 78 or 79 years. The Healthcare professional reported that SHINGRIX dose was administered at a different facility. The lot and expiry date were unknown.
Pt. came into the clinic at  230pm and I drew up vaccine and gave in L arm at 245PM. Went back to my desk after  left and realized the expiration date was 6/14/23, not 6/23/23.
vaccine administered 1 day after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 1 day after puncture) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 1 day after puncture). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 1 day after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-332851 .   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received include no new information.
Pt vaccinated wih Influenza A/B throat constricting, tightness in chest, anxiety.