chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hep B titer was 3; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   Additional Information: GSK receipt date: 07-Feb-2023 Reporter's comment: The nurse administered 4th dose of Engerix B pediatric formulation to a patient. The Hepatitis-B titer was 3.  The reporter consent to follow up. Additional supportive information: The patients received doses of Hepatitis-B vaccine series and had insufficient titers of Hepatitis-B, which led to therapeutic response decreased. Note: 4th dose of Engerix B pediatric was not captured as suspect as it seems it was received as corrective action for low titer and as per start date it could not possible antibody developed in 1 day.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (Lot# L008996 and Expiry date. 01-DEC-2016; Lot# K022995 and Expiry date. 22-JUL-2016; Lot# K010223 and Expiry date. 13-MAY-2016; Lot# K014826 and Expiry date. 28-MAY-2016; Lot# K009752 and Expiry date. 15-APR-2016; Lot# L000569 and Expiry date. 13-JUL-2016). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Around May, heart palpitations, rapid heart beat, and skip beats. I would have them in the pass. The events up ticked significantly. To where I went to a heart doctor to try to monitor and capture it, to make sure it's not anything super serious. At the end of August, I had CT scan make sure there is no blockage in the heart, The monitor did not capture all the events I was talking about. The results were inconclusive. The 2 week monitor I was put on did not last it's 2 weeks because the battery died early. I am going for a second round to have my heart monitor. I am waiting for a call back from the specialist to schedule an appointment. I do not know if my symptoms have anything to do with the vaccine. I have not had any lifestyle changes that could be attributed to be a cause of this. I do not attribute the AEs to the 2nd shot. It is not keeping me from getting my 6 month booster. The heart palpitations, rapid heartbeat and skipped beats are still occurring I am still having the AE multiple times a week. I am still being monitored and have an appointment with a specialist, so hopefully we can catch it this next round.
This medically confirmed spontaneous report (initial receipt 26-SEP-2014) concerns a female patient. On 24-SEP-2014, the patient received AFLURIA (batch number not provided) intramuscularly. On 24-SEP-2014, the patient experienced a rash all over her body. The patient's primary care provider was aware and gave her something to treat the rash. She felt much better on 26-SEP-2014. Outcome was reported resolving on 26-SEP-2014.  Reporter's comments: The reporter assessed the causality as possible in relation to AFLURIA.
pt recvd vax;w/ 3rd inject,devel a marked indentation at inject site;in the ensuing yr & a half the area has completely filled w/ tissue;
Information has been received from a nurse practitioner concerning a 20 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported). No other vaccines were administered with GARDASIL. The nurse practitioner stated that the patient experienced swelling of her eyes after the vaccine administration. The patient would not receive any additional doses of GARDASIL. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the nurse practitioner who stated that the 18 year old (also reported as 20 year old) with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical condition, on 09-SEP-2010 at 9:45 was vaccinated into the left deltoid with the first dose of GARDASIL (lot # 0405Z). The nurse practitioner reported that on 09-SEP-2010 in the evening, after receiving the vaccine, the patient complained of swelling around her eyes. There were no other symptoms. The symptom resolved with BENDRYL. Next day, on 10-SEP-2010, the patient had recovered. No laboratory tests were performed. Additional information is not expected.
Developed a right leg DVT 3 weeks after receiving first dose of Moderna COVID19 vaccine.   Per providers note: Possibly provoked by COVID immunization 3 weeks prior with extensive occlusive clot extending from the right femoral vein just distal to the confluence of the greater saphenous vein through the popliteal vein into the peroneal and posterior tibial veins.
9/16/05 (11:30am) The mother says that the same day the right arm was red, hot and the injection site had a black mark. He did not have a fever. Was taken to the doctor that explained that it was a vaccine reaction that produced cellulitis. Child was medicated. Right arm was red, hot, it measured 80mm.
Moderna COVID-19 vaccine EUA. On day 9 after receiving the vaccine I noticed a large bullseye on my left arm in the location that the shot was given with heaviness and tiredness in the muscle. The previous day I felt a little tired and run down with slight runny nose and sneezing.
Narrative: Day of shot pt reports nausea and resolved that evening. pt reports pain at injection site the next day after the shot and self resolved within 3 days. Muscles aches on day 2 took Ibuprofen and resolved that day. Fatigue on day 3 followed by a fever on day 4 which self resolved that day.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as between 27-OCT-2015 and 18-NOV-2015) the patients were vaccinated with unspecified doses in the series of GARDASIL 9 (unknown route and strength) (lot # 007560 with expiry date of 15-JUN-2017 or lot #L016428 with expiry date of 30-JUL-2017 or lot # L020015 with expiry date of 16-AUG-2017) which were improperly stored. No adverse effects were reported. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
pt c/o sensation in throat as if it was swollen;itching;few hives;
Pfizer COVID-19 Vaccine EUA. Shortly after administration of the vaccine, customer reported dizziness , nausea, and overall warmth. After sitting in the waiting area for an additional 15 minutes with an ice-pack and water, customer's symptoms were relieved and she was comfortable to leave the store.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, with outcome of unknown. Additional information: It was reported the patient received second dose on Apr 1, 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a physician concerning a 17 month old white female with seasonal allergies, no medical history, no history of chickenpox and no recent exposure to chickenpox or herpes zoster, who on 06/26/02 was vaccinated SC in the right arm with a 0.5mL first dose of varicella virus vaccine live (Lot # 640313/0967L).  On 06/26/02 the pt was also vaccinated IM in the right thigh with a third dose of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 637873/1523K), a fourth dose given IM in the left thigh of Prevnar (Lot # 484871), and a first dose given SC in the left arm of MMRII (Lot # 639571/1207L).  The pt had a bilateral acute otitis media which was being treated with Omnicef at the time of vaccination. There was no other concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of the vaccination.  On 12/14/02 the pt's symptoms began with a red, raised rash with vesicles to her right labia and inner thigh. It involved the L1 dermatome. The pt had no fever. The pain was rated a 4 on a scale of 1 to 10.  The rash was initially treated with hydrocortisone cream by the pt's parent with no result. On 12/16/02 the pt was seen by her physician. The pt was diagnosed with herpes zoster. She was initially treated with Zovirax by her family physician. She was then changed to Famvir by a dermatologist. Subsequently, the pt fully recovered. No product quality complaint was involved. No further information is expected.
S/P vaccination 10/12/17 developed erythema, swelling, and pain to proximal L. upper extremity. Next day, she had subjective fever, fatigue, and myalgia's.
Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; This is an initial spontaneous report received from the non-contactable consumer (patient himself). A 24-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7533) via an unspecified route of administration in left arm on 05Apr2021 18:00 as 2nd dose, single dose and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in left arm on 18Mar2021 13:00 as 1st dose, single dose for COVID-19 immunization. Patient was 24-years-old at the time of vaccination. Patient medical history was not reported. Patient had no known allergies to food, medications or other products. The concomitant medications included ibuprofen (ADVIL MAX) and amoxicillin at a dose of 500 mg. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient woke up during night after the vaccine with chills and body aches. Following day after the vaccine patient had a fever, body aches, chills, and a headache throughout the whole day. Two days after the vaccine, all symptoms cleared except the headache worsened. The patient did not receive any treatment for the adverse events. The outcome of the event headache was not recovered while for other events was recovered.   No follow-up attempts are needed. No further information is expected.
got shingles after each inlection; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported. The reporter knew the patient who got shingles after 1st injection. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR178318.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178318:Same reporter
expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 21-JUL-2023, the patient received Kinrix. On 21-JUL-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUL-2023 Nurse stated that a patient today was administered an expired dose of Kinrix, which led to expired vaccine used. Permission for follow-up was not asked,
got the flu; it's a flu shot, It's only usually about 40%-60% effective anyway; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who got the flu and it's a flu shot, it's only usually about 40%-60% effective anyway after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on batch number was requested.  On an unknown date the patient got the flu (influenza) and it's a flu shot, it's only usually about 40%-60% effective anyway (therapeutic response decreased) (unknown latency).  It was reported that ".Last time I got a flu shot 14 years ago; I got the flu. Haven't had it since."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for both the events.
Case number PHEH2015US019342, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 06 Aug 2015 and the vaccine administered was stored in (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO was administered intramuscularly on the right deltoid.
Large local skin reaction with swelling >2 cm, redness, induration. Swelling still present. Monitoring located on right thigh - site of MMR.
Urinating a lot after booster; Tremendous amount of urine after booster; Rough Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster). At the time of the report, POLLAKIURIA (Urinating a lot after booster), POLYURIA (Tremendous amount of urine after booster) and HEADACHE (Rough Headache after booster) outcome was unknown.            No concomitant were reported.  Patient stated that patient did not have a history of UTI and dose not think it was UTI.  No treatment were reported.   This case was linked to MOD-2022-437599, MOD-2022-437614 (Patient Link).
After I fell asleep I woke up around 2 am with fever and chills; After I fell asleep I woke up around 2 am with fever and chills; rash and itching on my abdomen, face, arms, and lower pelvis.; rash and itching on my abdomen, face, arms, and lower pelvis.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration on the right arm on 20Apr2021 at 09:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (with medications blood pressure was normal then) and known allergy to latex. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) 150 mcg; lisinopril (MANUFACTURER UNKNOWN) and diltiazem (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 21Apr2021 at 02:00, the patient woke up with fever and chills, rash. The patient then went back to sleep and woke up with rash and itching on abdomen, face, arms and lower pelvis. On 25Apr2021 (reported as today), even with benadryl and hydrocortisone cream (prescribed by the doctor), the patient was still itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events rash and itching on abdomen, face, arms and lower pelvis and included treatment with diphenhydramine hydrochloride (BENADRYL) and hydrocortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events fever, chills, rash and itching on abdomen, face, arms and lower pelvis was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Narrative:  88yo MALE with a h/o COPD on home O2, chronic diastolic heart failure, pulmoary HTN, chronic orthostatic hypotension, with h/o PE on Apixaban who was admitted on 8/6/21 to the ED from nursing home for episode of soa died on 8/7/21 after transfer to inpatient hospice care.Death was caused by: Acute cardiopulmonary arrest in the setting of Acute on Chronic Hypoxemic Respiratory Failure . Pt had received covid-19 vaccinations in 1/19/21 & 2/17/21. Death is not related to vaccinations.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent. A 11 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RHINORRHOEA (non-serious) with onset 25Nov2021, outcome "not recovered", described as "runny nose"; COUGH (non-serious) with onset 28Nov2021, outcome "not recovered", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer said that her 11-year-old son received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 12Nov2021. Last Thursday, 25Nov2021, he started having runny nose, and yesterday, 28Nov2021, he started to have cough. She said her son is scheduled for his 2nd dose on Friday, 03Dec2021, and wants to know if he should proceed with it despite his symptoms. She said she had him tested for Covid this morning. She wants to know if he should still push through with the 2nd dose if he tests negative but still has symptoms or if he should wait instead. ORANGE CAP: Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for 5 through 11 years of age- DILUTE BEFORE USE. Version: 1; LAB-1486-1.0; Revised: 29Oct2021.Caller says her son's runny nose started on Wednesday or Thursday last week, she thinks on Thursday. She says his cough started yesterday on Sunday. AE Treatment: None. AE Outcome: Caller says as far as the runny nose and now he has cough, she would say that is getting worse. She says the cough has stayed the same. Follow-up attempts are completed. No further information is expected.
High levels of unsteadiness, vertigo, and brain fog. Treatment includes vestibular exercise therapy and dramamine. Symptoms worsen over the course of the day and are triggered by movement.
Approx. 2 hours after receiving the flu vaccine. Patient had a scratchiness in her throat. Ate her lunch & felt clammy, sweaty, fuzzy and nauseous. At 1:50pm she was pale, sweaty & had a hard time breathing. She vomited & had leg cramping. She was transferred to ED where she was given IV fluids & nausea medication & discharged. She had chills and a low grade fever with laryngitis & scratchy throat for 4 days.
Info has been received from a 27 y.o. female pharmacist who on 5/13/02 was vax'd w/a first 10 mcg dose of Hep B vax recombinant. On 5/13/02 the PT developed a rash around the inject site. On 5/15/02, it was reported that the PT still had the local inject site rash. PT stated she "thinks that she may have allergy to thimerosal, but not sure". Unspecified medical attention was sought. Add'l info has been requested.
Chills, rapid heart beat, BP-112/62, general weakness, nausea, vomiting.