chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. On 14th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
Patient experienced swelling of the face. Patient came in the following day  and was recommended to go to physician. Patient received steroids after dose. Patient is requesting documentation that if a booster is made, that he is not eligible to receive booster.
covid shot 2/2; feel bad 2/5; covid positive diagnosis  - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted  went into DIC per intensivist 2/11 patient died
patient was very worked up about getting vaccines and intern spent several minutes waiting for patient to be ready for injection. She did not allow intern to give one vaccine per arm as planned and instead asked for both in the same arm. The second shot was giving in the lower part of the arm below the deltoid muscle. The patient reported immediate pain  radiating into her armpit, and bleeding from second injection site.  Two days later patient was still experiencing stabbing pain in their upper arm and armpit for a 7/10 pain. Patient went to pediatrician for pain treatment and they believe it injured the axial nerve.
Chest pain about 24 hours after receiving booster dosage; Slight pain when breathing in; Primary immunisation: Moderna; Booster: BNT162b2; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FJ1611) at the age of 19 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot Number: 021B21A; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 13Apr2021, when the patient was 18 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot Number: 036B21A; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 11May2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 07Jan2022, outcome "unknown", described as "Primary immunisation: Moderna; Booster: BNT162b2"; IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "Dose number: 3"; CHEST PAIN (non-serious) with onset 08Jan2022, outcome "recovered with sequelae", described as "Chest pain about 24 hours after receiving booster dosage"; PAINFUL RESPIRATION (non-serious) with onset 09Jan2022, outcome "recovered with sequelae", described as "Slight pain when breathing in". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain and painful respiration.  Additional information: It was reported that chest pain was throbbing, dull pain that later intensified has later died down and reduced the morning after when pain reliever taken Therapeutic measures included pain-relieving medications (unspecified). The event had improved but was still present albeit at a lower pain intensity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
The day after the first dose -I experienced extreme fatigue and  increased episodes of self aware A-fib. I slip into and out of A-fib many times a day, but usually am not aware when it's happening, but after the vaccine, the A-fib signs were much stronger than usual and I was very well aware when I went into A-fib. This became even stronger after the 2nd dose. My electrophysiologist's office said they are getting similar reports from other patients as well. They've scheduled an appt for a holter monitor for Friday May 21st and a video appt with the Dr for June 1st.  Also, within 10 minutes of the 2nd dose I became very dizzy and my heart was racing. The nurse had me stay at the clinic until my heart rate settled down. The dizziness persisted into the next day. The day after the 1st dose, my peripheral neuropathy worsened, and within 8 hours of getting the 2nd dose it became considerably worse than it had gotten after the 1st dose.
72 years old administered fluzone qiv instead of the fluzone hd qiv with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received via Nurse. Agency number: 01337732.  This case involves a 72-year-old female patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered instead of the fluzone hd qiv with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given.    On 25-Oct-2022, the 72-year-old patient received suspect fluzone qiv at dose 0.5ml once (lot: UT7701MA, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for immunization instead of the fluzone hd qiv with no reported adverse event (wrong product administered) at same day latency.  It was reported that "Nurse called stating a patient received the FLUZONE QIV instead of the FLUZONE HD QIV. Caller inquired if the patient needs to be revaccinated or how to proceed with ensuring the patient is fully vaccinated. The nurse who gave it was very upset and when the nurse came back from lunch put her on the phone. Says the patient just walked in and asked for a flu shot because she had been in the office the day before but went home and forgot to get it. Physician didn't order a specific vaccine and discussed with the nurse the patient is age appropriate for Fluzone Quadrivalent, but she says her company is making a hard push that anyone over 64 years old they should give them the Fluzone High Dose Quadrivalent. The company is pushing to give anyone over 64 should be getting the Fluzone High Dose Quadrivalent."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Hives, welts, itching skin, burning sensation in skin, am taking 25mg Aterax every 6-8 hours and Triamcinalone cream
Per patient, had allergic reaction after vaccination. Swelling and redness on face. Tried benadryl but it made the symptoms worst. She she consulted her dermatologist and her dermatologist prescribed Lisinopril 5mg for 7 days to help with the swelling on 1/13/22.
RASH, AND ITCHING 30 MINS. AFTER RECEIVING THE VACCINES.
Red rash extending down from the injection site. First appeared 3 days after the injection. Still present at 5 days. Looks similar to images of  covid arm.
unable to speak, gray color, partial facial paralysis. Hospital test found new on-site heart irregularities  after the vaccine. administration. Conditions did not exists prior to vaccine. Vaccine Johnson and Johnson. This was the second shot.
Information has been received from a registered nurse concerning an 18 month old female who on 02/11/2002 was vaccinated with a dose of varicella virus vaccine live. On 02/21/2002 the pt developed 8-10 lesions, on her abdomen and chest, and a temperature of 102.6 deg F. It was reported that there was no treatment. The pt sought unspecified medical attention. Additional info has been requested.
I filed a Medwatch report a few days ago, too, but wanted to report two more incidences of this. I have been having issues with the Abrysvo RSV vaccine dissolving completely after reconstitution. These affected vaccines have had very small/fine particulate matter in the reconstituted vaccine resembling anything from tiny grains of sand to small flakes of white paint. I have called Pfizer to report this as well, and will call them again during the week as I had two more kits do the same thing today. Basically every single kit I prepare, the vaccines dissolves completely fairly quickly (<2 minutes). These affected kits dissolve, but there is visible particulate matter. It was present when I looked at the vials about two hours after reconstitution. Last week I checked the affected mixed vials 5-6 hours after preparation and these was still some visible particulate (1 vial had visible particulate matter, 2 vials seemed to have cleared up completely). I did not use any affected kits to immunize patients; the six kits from last week were all discarded. I saved the two kits I went through today to get one that would dissolve. All kits are from the same supplier (ABC/Amerisource Bergen), have been stored under appropriate conditions, arrived in the same shipment, are the same lot number and expiry for all components of the kits (vials, syringes of diluent, and adapters) --- vaccine vial L: HF5014 E: 02-28-25; diluent syringe L: GY5655 E: 2-28-25; adapter L: F656 E: 05-01-27 REF: 8070117.
now I have 2inch mild red wring; that is warm to the touch where I got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (now I have 2inch mild red wring) and FEELING HOT (that is warm to the touch where I got the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (now I have 2inch mild red wring) and FEELING HOT (that is warm to the touch where I got the shot). At the time of the report, ERYTHEMA (now I have 2inch mild red wring) and FEELING HOT (that is warm to the touch where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Headache, body aches, fever, chills, nausea, treated with Tylenol 1000 every 6 hours had to back up with ibuprofen 400 in between the Tylenol doses for the second day to keep down fever and make it between doses. Otherwise I was hurting and fever would rise. Also took Zophram for nausea.
During observation period member had what appeared to be a seizure lasting less than 1 minute - head fell back, rolled eyes, trembling. Confused when episode ended for about 15-20 seconds then became oriented and answering questions appropriately.  Patient vomited face became very pale, complained of feeling hot and "not right' transported to ER via EMS
Hot red spot (101 F) on upper right arm, size about 6 inches, near injection spot, lasted for 48 hours
greater than 35 days between doses of the Moderna Covid-19 vaccine; Migraine Headache; Fever; chills; muscle aches; joint aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine), MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills) and MYALGIA (muscle aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine), MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine) had resolved. At the time of the report, MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatments were provided.
Fever of 103.5; severe body aches; Migraine; Fatigue; Insomnia; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 29Dec2020 at 15:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included GERD and allergy to latex. The patient was also diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has concomitant medications but were not specified. On 01Jan2021 at 02:00, the patient experienced fever of 103.5, severe body aches, migraine, fatigue, and insomnia. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
6 months after receiving COVID-19 vaccine, tested positive. Dr. prescribed doxycycline.
This report is a vaccine error. The Pfizer vaccine was given on 3/25/2021, followed by the Moderna vaccine on 4/6/2021. Mixed vaccine was given. No known signs or symptoms were reported regarding this incident.
pt recv 2nd dose of vax & exp inc erythrocyte count, tracheal ulcers which caused diff breathing, herpes like synd, colitis, EBV & mono;pt hosp & dx Paget's disease 1997;pt recv 3rd dose of vax in 1997;
Had the PREVNAR 13 vaccine applied at Pharmacy on Friday 12/8/2017 at around midday. That evening began to experienced chills, redness at site of injections, joint pain, nausea, complete loss of appetite. These symptoms continued in its majority until Tuesday, 12/12/2017. The chills, nausea, joint pain completely gone, however high redness at site of injection still present today 12/13/2017.
5 days after the 2nd dose of moderna vaccine my husband started shaking severely, his whole body, stating he was freezing and he had trouble walking, he wobbled to his recliner. I covered him with several heavy blankets and he continued to shake in episodes of 10 - 15 seconds, then it would stop for 10 -15 seconds and start again. I tested his blood sugar which was 80. He did not have a temperature. This shaking continued for about 1 hour before slowly subsiding and gradually fading away. He then slept for 2 hours.  He  awoke the next morning with a moderate headache and a temp of 99.5 and felt achy all over. I gave him 2 extra strength tylenol and left for work. At 10:30 am his temp was still the same he took more tylenol. I called his physician, a nd reported his symptoms to the nurse. The doctor felt it was a reaction to the vaccine and recommended rest, fluids and tylenol.
Myalgia, Arthralgia, Fever, ErythemaMultiform, chills, sweats, extreme arm soreness Narrative: Extreme arm soreness, fever 99.8, myalgia, arthralgia, chills, sweats; mostly resolved at 24 hours.
flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.            concomitant medications were not  provided.  No treatment information provided.
Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids
pt recv vax 17DEC97 & pt had bilat OM & cold signs & sx @ the time of vax;pt exp extreme but not complete hair loss on the scalp;
I accidentally administered a Bivalent dose for the patient's primary series. Patient was supposed to receive a monovalent dose. Upon acknowledging my error, I immediately notified the patient and informed her that we would be proceeding with CDC recommended guidelines. "If a bivalent Pfizer-BioNTech vaccine is administered for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose. Continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Pfizer-BioNTech vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series)."   I made notifications on the patient's 8-week appointment for her second dose so that she would receive a monovalent dose. Patient was a bit apprehensive, but I assured her that we were following CDC recommended health guidelines and we would be completing her first series with a monovalent on her next dose. Patient understood and acknowledged the health recommendations.
per ED Note: The patient presented to the emergency department due to pain in her right lateral rib cage. This pain is worsened by deep inspiration. She denies any hemoptysis or unilateral leg swelling denies calf tenderness. The patient states that she initially developed upper respiratory symptoms on the 11th and had a dry cough as well as sore throat, fevers and chills headache and body aches. She tested positive for Covid on the 13th at an outside facility. She states that the majority of her symptoms have significantly improved since that time but today she developed this pain in her right lateral lower rib cage with deep inspiration. She states it is more pain with deep breath than necessarily shortness of breath.
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included NAPROXEN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
vaccine administration error regarding Pfizer lot # GL0087  administered on 02/21/2023 with beyond use date of 02/17/2023 with recommendation to get booster at local pharmacy
sore throat, persisting, to large cold sore on throat, now in its fifth day.
Initial unsolicited report received from a Consumer via other company (pfizer) on 11 January 2016. Manufacturer number: 2016002211. This case involves a male patient (age: 24-25 years) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, dose number, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination the patient felt ill. Lab data and corrective treatment was not reported. The outcome of the events was unknown. List of documents held by sender: none.
Pt given Rota vaccine at 4 month visit. Initial dose is out of recommended guidelines.
Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 06-NOV-2018  the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007541: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: