chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Previous excursion on the same products in June 2020 at a high of 49.8F for 2 hours with no adverse event; IPOL MDV is opened and one patient has been administered a dose since the excursion in June 2020.; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who had administered a dose of IPV (VERO) [IPOL] since the excursion in june 2020 and previous excursion on the same products in june 2020 at a high of 49.8F for 2 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received of suspect IPV (VERO) for suspension for injection (lot VIA024M, dose, formulation, strength, expiry date: unknown) via unknown route in unknown administration site for immunization and ipol mdv opened and one patient has been administered a dose since the excursion in june 2020 (poor quality product administered), previous excursion on the same products in june 2020 at a high of 49.8f for 2 hours with no adverse event (product storage error) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  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.
Moderna COVID-19 Vaccine EUA Dizziness, rapid heat beat, shortness of breath 20 min. after injection
PATIENT REPORTED ERYTHEMA AT INJECTION SITE, ITCHING, LOCALIZED TENDERNESS & PAIN. INJECTION SITE WAS A TAD BIT WARM AT TOUCH. PATIENT REPORTED SLIGHT CHILLS ON 4/6/16 BUT FEELS BETTER TODAY.
The pt experienced a fever of 102-103 from 9/7/01 through 9/15/01. No other symptoms, seemed prolonged fever.
Caught covid; Caught covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "recovering" and all described as "Caught covid". No covid prior vaccination. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (10Oct2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild flu symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020107111).   On 12th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Nurse reported the case for her husband who was a physician. The age at vaccination was not reported. The patient received Shingrix in left arm and and experienced mild flu symptoms for a couple of days and then resolved. The reporter consented to follow up. The reporter could follow up with the reporter directly. This case linked with US2020107109, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107109:same reporter US-GLAXOSMITHKLINE-US2020107111:same reporter
hives noticed next morning hives faded p/DPH & almost gone by the time got to ofc;
first dose on 4-DEC-2020, never came for second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, till the time of reporting, the patient never came back for the second dose within recommended timeframe, which led to incomplete course of vaccination. The lot number or expiration date was not available. The reporter consented to follow up and provided email for follow up.
RECEIVED FIRST DOSE MODERNA ON 4/9/2021. RECEIVED SECOND DOSE PFIZER ON 5/7/2021.
Developed Migraine and Nausea. Nausea lasted for 4 hours. Has hx. of migraines and has prescription for Imitrex. Took Imitrex with onset of migraine
patient received a second dose of boostrix one year after his first dose. patient was not due for this vaccine. patient is not currently experiencing any signs or symptoms
Fever 102.3-102.4 x 4 days. (L) thigh indurated/red/hard/hot. TYLENOL PRN.
Patient states she developed a "bad taste" in her mouth immediately upon administration of vaccine. Alerted staff that she needed to throw up shortly after. Brought to the restroom and had several episodes of projectile vomiting. No recent known illness, had not had breakfast yet (wouldn't normally have eaten), does not believe she is pregnant.
This infant died of cardiopulmonary arrest of unknown etiology; at this time autopsy is pending. Autopsy stated cause of death as  acute encephalopathy.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant medications included sterile diluent. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU; lot # N016090 and expiration date: 23-AUG-2018 (dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that incorrect storage of ZOSTAVAX lasted 10 hours at 9° F; and the call was given because of a data logger. Previous temperature excursion had not occurred. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008253.
Pain and tingling in my left arm,, into my shoulder and through my collarbone, to my neck and itno my jaw
Presented to ED 5 days post vaccine with acute respiratory failure with hypoxia and signs of sepsis including fever, tachycardia, and tachypnea, with lactic acidosis and hypoglycemia.
Severe reactions yesterday and last night (4/9/2021): chills, fever, fatigue, headache, heavy chest, difficult breathing, palpitations, high pulse rate, joint aches and pains, dizziness
This initial spontaneous case, was received on 23-Oct-2017, from a pharmacist, concerning a 61-year-old, adult female patient. The vaccine history included, unspecified quadrivalent vaccine in the previous year with no issues. On 13-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195239, expiry date: May-2018, anatomical location: not reported). On 15-Oct-2017, the patient developed red itchy patch on leg. It was reported that, in the following days, the patient developed red itchy patches on the heel on the opposite leg, which then progressed to arms, hands, face, the corners of her eyes, neck, and inside of her ears. The patient consulted a physician and was given unspecified corticosteroids. At the time of this report, the patient was recovering from the event. The reporter assessed the event as non-serious.
Initial report received from the consumer on 17 Dec 2009: This patient received FLUVIRIN lot number 102136P1A, intramuscularly on 17 Nov 2009 at 01.45 pm. On the same day at 02.00 pm, the patient experienced metallic taste and taste disturbance. The outcome of the event was reported as ongoing.
This case was reported by a nurse and described the occurrence of injection site soreness in a 39 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject had no known allergies. There were no concurrent medications. On 28 November 2005 the subject received 2nd dose of Engerix-B in the left arm (lot AHBVB144BA). On 28 November 2005, 5 hours after vaccination with Engerix-B, the subject experienced "soreness from shoulder to elbow of the injected arm" and chills. The subject was treated with Tylenol on 28 November 2005. At the time of initial reporting, 29 November 2005, the events had improved. The nurse considered the events to possibly be related to vaccination with Engerix-B.
Major numbness and tingling in both feet.  Toes are tight and hard to bend.  Hands have periodic sharp pains to go through.  Weakness and fatigue and jittery feeling in legs.  Pressure at the bottom of throat which is worse while lying down.  Bug crawling sensation over body, but mainly in the legs.  Muscle spasms and cramping. Eyes feel like you are looking out a fish bowl.   After 30 days the entire body got extremely tight and hard to bend, hard to wash feet.
Severe pain reported by patient in area of injection site. Small surface bruising. Patient required medical attention. Sent to Urgent Care facility for xray. 4-5 days for complete recovery.
Information has been received from a mother concerning her 8 year old son with side effects to any kind of sedative who at the age of 2 was vaccinated with MMR. The patient was reportedly screaming all day when he received the vaccination. Subsequently, the patient had a fever for a couple of days was vomiting, developed a rash, and was lethargic. The patient was diagnosed with attention deficit hyperactivity disorder soon after receiving the vaccination. It was also reported that the patient had dental work and was rushed to the hospital due to side affects.  Follow up information was received from a nurse practitioner concerning the 8 year old male patient who on 7/25/97 and on 8/24/04 was vaccinated with a first and second dose (lot # 648461/1306N) of MMR respectively. It was reported that following the second dose the patient developed a headache for three days and had recovered. It was also noted that on 9/13/96, 11/22/96, 1/17/97, 1/23/98 and 8/16/00 the patient was vaccinated with diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 3/3/04 and on 8/24/04 the patient was vaccinated with hepatitis B virus vaccine. On 9/13/96, 11/22/96, 1/17/97 and 1/23/98 the patient was vaccianted with HIB conjugate vaccine.  Upon internal review, rushed to the hospital due to side effects was considered to be an other important medical event (OMIC). It was also reported that the patient's sister also had an adverse experience following vaccination with MMR. Additional information has been requested.  Follow up on 11/02/04 states: "Follow up information was received from the reporting nurse who stated tha the child was vaccinated with a second dose of MMRII, in the right anterior thigh, SC. Concomitant vaccination that day included a second dose of Hepatitis B virus vaccine rHBsAg (yeast)(Engerix B)(Lot # ENG5570A2), in the left anterior thigh. There was no illness at the time of vaccination. Concomitant medications on 08/24/04 included methylphenidate hydrochloride (Concerta). According to the mother, on 08/24/04 the pt developed a headache for 3 days after immunization. The pt reportedly was never seen in the office. The pt recovered from headache. Upon internal medical review "rushed to the hospital due to side effects" was considered to be an other important medical event (OMIC).  It was also reported that the pt's sister also had an adverse experience following vaccination with MMRII (WAES #0408USA01844). Per mother, 'both children have reactions with every shot given.' No further information is expected." Follow up 03/03/05: Patient's recovery status is unknown.
Injection site pain to the point where he refuses to walk or move at all without being held.  He wouldn't even sleep by himself, he had to sleep on my chest with his legs hanging off to the side.  he would cry if i brushed up against his left leg and he was also very sensitive in his right leg.
Extreme fatigue, loss of appetite, achy, general flu symptoms, overall terrible, coughing
loss of smell; loss of taste; congestion; fatigue; sore throat; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue) and OROPHARYNGEAL PAIN (sore throat) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include unspecified antibiotics. No treatment information were provided. Sore throat started on Friday, and congestion started on late Friday / early Saturday. Patient had soreness in the arm (the right arm) over the weekend and loss of smell and taste started on late Sunday / early Monday.
Per employee in her own word on reporting documentation (Fridays date was 11/18/2022):  went to bldg 2nd floor for covid booster on friday 11/19/2022, over the weekend i felt dizzy headache body aches chills diarrhea and nausea and left arm and side all the way to breast swollen tender and pain full. came to work Monday to advise supervisor and to see what I need to do .had to have my husband dress and drive me to work. nothing just resting and keeping my arm from not touching my body due to the extreme pain . Taking over the counter tylenol and ibuprofren. had the covid booster
itching got really annoying; rash spread to different parts of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Nov2021 12:00 (Lot number: fh8030) at the age of 74 years as dose 3(booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=fl9262, prev dose lot unknown=False, prev dose administration date=17Mar2021, prev dose administration time=03:00PM , prev dose  dose number=2, after 2nd shot got minor itching), administration date: 17Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "got minor itching", "some minor rash,mostly on back of"; Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=en6201, prev dose lot unknown=False, prev dose administration date=24Feb2021, prev dose administration time=02:00PM , prev dose vaccine location= Left arm, prev dose  dose number=1), administration date: 24Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:00, outcome "not recovered", described as "Booster"; PRURITUS (non-serious), outcome "not recovered", described as "itching got really annoying"; RASH (non-serious), outcome "not recovered", described as "rash spread to different parts of my body". The events "booster", "itching got really annoying" and "rash spread to different parts of my body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of immunisation, pruritus, rash.  Additional Information:It was reported that patient did not had any other vaccine in four weeks. And  The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. And had no known allergies. Other medical history: none After 2nd shot got minor itching and some minor rash, mostly on back of arms, After 3rd shot itching got really annoying and rash spread to different parts of my body. Using anti itching creams. seems to help, but problem is still intermitant.  No follow-up attempts are possible. No further information is expected.
Started with chills, then fever of 99-100.  Fever tx with tylenol. Fever on and off from 4/2/2021-4/4/2021.  Poor appetite, slept alot.  Big round red swelling, hot to touch lasted 5 days, and still 7 days later large bruise, more blue/purplish remains on arm. Still the same size.
slight fever, lethargy, headache, body ache, lymph node under left arm was swollen and painful
Discharge Provider: Private MD Primary Care Provider at Discharge: Private MD Admission Date: 8/13/2022 Discharge Date: 8/13/2022 DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 65 y.o. female who presented to local Hospital as a transfer from ED for hypokalemia. Patient initially presented to emergency department for nausea, vomiting, diarrhea, and palpitations. Symptoms began 08/09/2022, and she took a home COVID test which was positive on 08/11/2022. Patient has history of low potassium and experiencing palpitations. In the emergency department she was found to have hypokalemia at 2.8, and intractable nausea. She was given potassium replacement, Zofran, IV fluids and sent to hospital for observation. On the general floor, patient had full resolution of nausea, vomiting, and diarrhea. She tolerated normal breakfast without difficulty. She did not have return of palpitations and repeat lab work showed resolution of hypokalemia. Patient was considered medically and vitally stable for discharge home.
I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables). At the time of the report, DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Patient administered expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial initially stored in the refrigerator was unknown. Total of 102 doses were given from LOT 026C21A with expiration date 24-Oct-2021. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow-up: Additional reporter added.
Per TC with mom diarrhea X 1 at 7 P.M. and blood in stool X 1 at 11 P.M. No fever- No vomiting. Breast Fed
I95.9 HYPOTENSION 5/26/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 5/26/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Initial misuse case was received from a healthcare professional on 16 OCT 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported receivd a 0.25 ml dose of FLUZONE on unspecified date. (Route, site, dose and Batch number not reported). It was reported that on an unspecified date patient received an incorrect dose of vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Following flu vaccine (FLUVIRIN 2010 2011 vial) my mother, became ill with vomiting, chills & achy. She became bedridden with symptoms coming & going for at least a week. I contacted her doctor & she had to go for tests. A blood test showed dehydration & will be repeated.
Fatigue, chills, body aches.  Bed rest and called in 3 days in order to rest. Haven?t been able to move a lot without substantial pain
difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.