chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt adm to hosp w/ c/o extreme fatigue/muscle weakness/dysuria;impression: abn liver enzymes/myositis/myopathy rhabdomyolysis, renal insufficiency secondary to rhabdo, dialysis required;Annual follow-up dated 11/01/00 provided no additional data.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subject experienced not responding to therapy (please see case numbers A0962819-20A and A0962822A for the other 3 subjects).
patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268092 (same reporter).  This case involves a 88 years old male patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date: 30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold, but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.   No adverse event reported at the time of reporting.  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.
This spontaneous report as received from a healthcare worker refers to a currently 18 year old female patient. In 2011 the patient was vaccinated with GARDASIL dose 1 (route, dosage and lot number not reported). In 2012 the patient received her GARDASIL second dose (route, dosage and lot number not reported). It was reported that the patient hadn't got her third dose yet. No adverse effect was reported. Additional information has been requested.
patient reported swelling at top of sholder and pain , that developed some time after injection was given . pt also received  fluad  quadrivalent  lot 279790 exp 5-25-2021 .  at this time I am unable to confirm which vaccine was given in his right arm
On 8-04-08 patient was administered a Pneumovax and a Zoster vaccine, 24 hours after she started experiencing high fevers of 102 and higher. On 8-08-08 she was seen in the ER, still with a high temp. Labs, x-ray and urine were analyzed, everything came back normal. On 8-12-08 she was seen in urgent care still experiencing a fever of 101.4, feeling sweaty and achy. She was put on antiobiotics for ten 10 days.
This is an initial report of an AE, received on 11Oct2016, for Protein Sciences FLUBLOK. Subject a 68 year old female, received FLUBLOK Intramuscular on 02Oct2016. On 02Oct2016, approximately six to seven hours after receiving FLUBLOK, the subject developed a sudden onset of an itchy throat that lasted for approximately two to three days and then resolved. She had no difficulty breathing. Medical and surgical history for the subject included multiple allergies and lactose intolerance. Concomitant medications were not reported.
Hospitalized 04/25/2022-04/26/2022; COVID-19 positive 04/25/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Admission Date: 4/25/2022 Discharge Date: 4/26/2022 DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is an 87 y.o female, hx of HTN, dyslipidemia, seizures, breast cancer s/p mastectomy, who presented to the ED following a mechanical fall.  Previously known family members recently tested positive for COVID.  Also noted to have unsteady gait.  In the emergency department, she was noted have a laceration above her left lateral are broad left upper lip which was repaired.  She was found to be COVID positive.  She underwent a CT head which showed a right uncal mass.  She also underwent a CT cervical spine which showed a C4 vertebral body lesion favored to represent a hemangioma.  X-ray of her ribs and knee showed no acute abnormality.  The case was discussed with Neurosurgery who recommended MRI of the brain.  Due to her history of breast cancer, it was also recommended to obtain a CT of the chest abdomen and pelvis.  She was admitted for further evaluation and management.   CT of the chest abdomen and pelvis showed a retroperitoneal mass which was unchanged from previous examination in 2019 with a stable appearance of the remainder of the abdomen and pelvis.  She also was noted to have a chronic T12 vertebral compression fracture.  She underwent MRI of the brain which showed a 1.5 cm right mesial temporal lobe lesion most consistent with a cavernous hemangioma.  Imaging was reviewed by Neurosurgery and recommended outpatient follow-up with no acute surgical intervention.  She was seen by PT/OT who recommended home with assist and outpatient therapies.  She was discharged home in stable condition.   Of note, hemoglobin drop from 11.3 to 9.9 without overt bleed, suspect dilutional with IVF given. Also with chronic mild neutropenia that could be contributed to her lamictal. Recommend follow up with PCP to discuss further.
After immunization patient developed petedriael rash of face.  Patient screaming a lot during shots
Forty-eight hours post dose I began to experience multiple episodes of prolonged, rapid, and irregular heart rhythm at rest. I visited a local Urgent Care on Dec 6 who referred me to a cardiologist. I went to a local Cardiology office and was prescribed a heart monitor for 14 days that revealed multiple unexplained episodes of tachycardia. I saw my general practitioner, who referred me to another Dr who ordered  an echocardiogram and stress test. I also visited a local Hospital ER for chest X-ray and ECG
Pt presented with guardian at point of sale to report fainting spell in the bathroom with guardian. Reported feeling clammy and nauseous after shot but attributed to anxiousness. Guardian said the the patient started tunnel vision while walking to the bathroom then collapsed onto guardian. She did not loose consciousness.  Had the patient sit back down in the waiting room. Her pulse was 80bpm regular rate and rhythm. Pale paler with clammy feel. Pt was alert and followed directions but did not speak for herself. Blood Pressure was taken 110/81 79BPM.  Vaccine was given about 12:30 with reporting to point of sale at 12:56pm Monitored patient for 5 more minutes. She was feeling better and able to stand with out any faintness. Sent on her way to call if any reoccurrence.
Two days after receiving GARDASIL, patient went to urgent care for bilateral rash on hands and feet that developed the same day vaccine was given. BENADRYL was recommended for pruritus and redness of hands and feet. Per the urgent care report, these symptoms began on 12-28-18.
April  2. Chills fever body aches headache cough.     April third extensive rash.    April 7 right breast hot swollen painful
Pt recvd vax & 24AUG92 1 month p/4th dose pt tested as surface antigen pos;
Patient developed pruritis on arms/back and felt some minor throat tightness.  Minutes later, itching had spread but no tightness in airway.  Patient was sent to ER for further evaluation and discharged without complication after brief observation.
dose administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that vial did not undergo any temperature excursion.   This case was linked to MOD-2022-533493 (Patient Link).   Reporter did not allow further contact
FEVER, COUGH, LOSS OF TASTE/SMELL, RN/CONGESTION, FATIGUE, SCRATCHY THROAT, EAR PRESSURE
Awoke with Major Chills/ Shivering, Muscle Pain over entire body, arm/shot site stiff and hurting, headache, upset stomach cramps, belly hurt and very tired and weak. Hurt everywhere, even Eye sockets.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) 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. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. In June 2021, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) had not resolved. No concomitant medications were provided by the reporter. No treatment was provided by the reporter.
Patient was diagnosed with shingles; With in 5 days patient was having pain on side/back; With in 5 days patient was having pain on side/back; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030259).  This spontaneous report was received from an other health professional referring to a 71 years old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 17-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot # M032141, expiration date was not reported) (strength and dose number were not reported) 1 dosage form, subcutaneously and with influenza virus sag 3v vaccine inactivated (FLUVIRIN 2016/2017) (lot # 1620401, expiration date was not reported) (strength and dose number were not reported) 1 dosage form, intravenously for immunisation.    On 21-OCT-2016, within 5 days patient was having pain on side/back (back pain and flank pain). On an unknown date, patient was diagnosed with shingles (herpes zoster). The outcome of the events was unknown. The causality between the events and zoster vaccine live (ZOSTAVAX) was not reported. The causality between the events and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2016/2017) was reported as not assessable.  The events back pain, flank pain and herpes zoster were considered to be medically significant by the reporter.
Fever of 100 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F) and PAIN (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever of 100 F) and PAIN (Body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 100 F) and PAIN (Body aches) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter.
Within 30 min observation period post vaccine, Ten minutes after vaccine injection patient began feeling dizzy and hot.  Monitor VS all within normal range. Gave water and allowed to lay and rest for full 30 min. Dizziness and hot feeling resolved discharged home @ 1234 with EC precautions.
pt recvd vax & woke to painful joints (enough to cause tears); c/o h/a in the back of head, tight neck & back muscles; no report of temp; c/o muscle cramps-generalized relief w/APAP & warm bath;
Development of varicella 5 years after receiving only one dose of varicella vaccine. Mother exercises personal belief exemption in completing vaccines. Onset of Upper respiratory symptoms about 1 week ago. Rapid onset of maculo-papulo-vesicular lesions on back, torso, scalp and arms
Feels like I had a shot of novocaine on upper lip; Feels like a bad allergy; I started itching-eyes, back and mouth.; eyes watery; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritus, increased lacrimation, oral hypoesthesia and hypersensitivity.    The patient's medical history included heart disease, sulfonamide allergy, kidney disfunction and vocal cord paralysis. Concomitant medications included carvedilol, ramipril, simvastatin, pantoprazole, Norco, duloxetine, aspirin-81.      On 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 63L5C20A) in the left arm for prophylaxis of COVID-19 infection.    On 19-Jan-2021, the patient experienced pruritus, increased lacrimation, and hypersensitivity. On 20-Jan-2021, the patient experienced oral hypoesthesia.   No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the events (pruritus, increased lacrimation, oral hypoesthesia and hypersensitivity) was unknown.
This is an initial report of an AE, received on 30Sep2016, for Protein Sciences FLUBLOK. Subject, a female, received FLUBLOK intramuscular on 29Sep2016. On 29Sep2016, within 15 to 20 minutes after receiving FLUBLOK, she experienced redness and swelling of her arms, face and throat that was accompanied by generalized itching. She was treated with diphenhydramine 25 mg, hydroxyzine 50 mg and diazepam 5 mg. At the time of the report, her symptoms had largely resolved. Medical history included a clinical, but not pathologic diagnosis of systemic mastocytosis and allergies to everything.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient Received vaccine beyond 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient received booster dose vaccination time was given as 18:13:56.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. Treatment medications were not reported.
1 wk p/vax, t105.9 w/rash;fever subsided p/24hrs;rash gone in 3 days;
Very mild COVID arm (red splotches, upper left arm).  Large 3 inch soft tissue lump on left clavicle. Not sure if lump is swollen node. Both conditions appeared suddenly when I awoke this morning.
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65.  My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
severe pain in chest; heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "severe pain in chest"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart issues".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from the authors of an article, concerning 3 female patients who on an unknown date were vaccinated with a dose of Quadrivalent HPV (manufacturer unknown). On an unknown date in the "1-7" day period following Quadrivalent HPV (manufacturer unknown) patients were identified with venous thromboembolism. Patient's outcomes were not reported. Methods: authors conducted a self-controlled case series analysis of venous thromboembolism (VTE) in six healthcare delivery systems. They identified potential VTEs among vaccinated women using coded inpatient and outpatient diagnoses from 2008 through 2011, and then manually reviewed them to confirm the diagnosis and collect risk factor (e.g., hormonal contraceptive, trauma, pregnancy) data. Study physicians adjudicated ambiguous cases. Observation time for each confirmed case was divided into exposed periods (7, 14, 28, 42, and 60 days following HPV4) and unexposed periods (the remainder of the observation period). They calculated the risk of VTE by dividing the incidence in exposure periods by the incidence in unexposed periods. Results: Authors identified 153 confirmed VTE cases in females 9-26 years of age who were exposed to HPV4 (manufacturer unknown) during the study period. Three VTE cases were identified in the 1-7 day period following HPV4 (manufacturer unknown) and the estimated relative risk in this period was 1.51 (95% confidence interval (Cl): 0.48-4.76). The risk estimate decreased with increasing exposure window length; the relative risk in the 1-60 day period following HPV4 (manufacturer unknown) was 0.95 (95% Cl: 0.55-1.62). In the 1-7 day exposure period the risk of VTE associated with HPV4 (manufacturer unknown) among hormonal contraceptive users was 0.88 (95% Cl: 0.12-6.35) compared to 2.44 (95% Cl: 0.59-10.12) among non-users. Conclusions: Authors did not observe a statistically significant increased risk of VTE in the 60 days following HPV4 (manufacturer unknown) exposure in young women. Statistical power was limited for examining potential effect modification by hormonal contraceptive use. The authors considered that venous thromboembolism was related to Quadrivalent HPV (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This report is linked to MARRS 1410USA015758, same literature report. Additional information has been requested.
After 15 minutes stepping down caused a sensation of blood splashing against my left fingertips.  20-30 minutes post vaccine splashing was replaced by my left hand going numb and felt like it was swollen though visibly was not. Numbness lasted about an hour. 40-50 minutes post vaccine nausea would come and go. 4 hours post vaccine the typical flu-like symptoms began: extreme fatigue, mild headache, muscle weakness, painful skin, lack of appetite.
The patient reported to have a large, red spot the size of a baseball that was also hard and hot to the touch. Additionally, she reported itching and pain at the site of vaccination.
Received vaccine 12/12/03.  On 12/15/03, woke with lymph node swelling over my collar bone and severe pain in shoulder.  Later that day it got to the point that I could not use my arm well.  The next day, 12/16/03, I went to the emergency room because of the pain and swelling.  The doctor treated it with a sling and pain medication and told me to follow-up if it does not resolve in 2 days.  The night of 12/17/03, I went to bed with chills.  On 12/18/03, at 1:00am I woke with severe pain in my shoulder.  I went back to the emergency room.  The doctor recommended that I remove the sling.  He gave me a prescription for doxycycline and some pain medicine.  I am still in a lot of pain, but will be starting the antibiotics today.
sore arm since injection; This spontaneous report was received from a physician via company representative refers to a 35-year-old female patient. Information on patient's historical condition and concurrent condition was not provided.   On an unknown date in March 2019, (also reported as about a month and half ago) the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in March 2019, (also reported as since the injection) the patient had a sore arm (injection site pain). None of the lab tests were performed. The patient sought medical attention. The patient received treatment with unspecified analgesic. At the time of this report, outcome of injection site pain was unknown. The causality of the event for the suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.