chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has Chronic Reflex Sympathetic Dystrophy of Right Lower Extremity; had an acute exacerbation of burning pain in the right lower extremity which is the affected limb; This is a spontaneous report from a contactable reporter (physician).   A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Nov2021 (Lot number: unknown) at the age of 56 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Clindamycin, reaction(s): "Drug allergy", notes: Known allergies: Clindamycin; Bactrim, reaction(s): "Drug allergy", notes: Known allergies: Bactrim and Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicilllin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot number: UNKNOWN Anatomical location: Arm Right, Route of Administration: Intramuscular), administration date: 15Oct2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: COMPLEX REGIONAL PAIN SYNDROME (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Patient has Chronic Reflex Sympathetic Dystrophy of Right Lower Extremity"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "had an acute exacerbation of burning pain in the right lower extremity which is the affected limb". The events "Patient has Chronic Reflex Sympathetic Dystrophy of Right Lower Extremity" and "had an acute exacerbation of burning pain in the right lower extremity which is the affected limb" were evaluated at the physician office visit. Therapeutic measures were taken as a result of complex regional pain syndrome and pain.  Additional information: It has been constant and has not stopped since patient's vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures included gabapentin (MANUFACTURER UNKNOWN) and GRALISE from an unknown date and unknown if ongoing.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt recvd 3 doses of Engerix-B & determined to be neg for seroconversion;
sore arm tiredness muscle pain chills sweats fever nausea feeling unwell decreased appetite diarrhea arm pain feeling of needing to vomit, but not vomiting
Information has been received from a Physician concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL vaccine (yeast). Lot number was not available. Subsequently, the patient experienced rectal bleeding. The patient did seek medical attention with the physician. There was no product quality complaint. Additional information has been requested.
First / on 11-3-2020 / scheduled / second / on 5-24-2021, 21 days late / due to Covid-19; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not applicable for this report. The patient received 1st dose and scheduled to receive her second Shingrix dose on 24th May 2021, 21 days late. The patient scheduled the second dose later due to Covid-19 and her availability to receive the second Shingrix vaccine. The patient confirmed that she did not ever got Covid-19 infection. The reporter did not consent to follow-up.
She noticed bumps on her knees today 03FEB2023; This spontaneous case was reported by a patient and describes the occurrence of RASH PAPULAR (She noticed bumps on her knees today 03FEB2023) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included MELOXICAM for an unknown indication.    On 02-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH PAPULAR (She noticed bumps on her knees today 03FEB2023). At the time of the report, RASH PAPULAR (She noticed bumps on her knees today 03FEB2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that 5 days ago the doctor gave her Meloxicam daily regimen. Patient took a Meloxicam tablet prior to vaccination.  No treatment information was reported.   Reporter did not allow further contact
A spontaneous report has been received from a physician concerning a 2 years 8 weeks old, male patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient administered the full dose of FLUMIST (intranasal) in one nostril (0.2mL) by clinic nurse. The outcome of incorrect administration was unknown. The reporter considered the incorrect administration to be non serious. The reporter and company physician considered that there was no causal relationship between incorrect administration and FLUMIST.
Case number PHEH2016US023403 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 59-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 21 Jan 2016. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 31-JAN-2013, the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Diarrhoea; itching; fatigue; weak; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE and VITAMINS NOS for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak). At the time of the report, DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak) had not resolved. Not Provided          No treatment was provided as per the reporter.
Hospitalization (9.10.21);  COVID-19 positive (9.9.21);  fully vaccinated  Chief Complaint/Reason for Admission: Acute ischemic stroke, s/p tPA ASSESSMENT & PLAN: NEURO: Acute ischemic stroke s/p TPA, suspect embolic/atherosclerosis vs hypercoagulable state in the setting of Covid + ;  TIA HPI:  Patient is a 68 year old with a PMH significant for Schizoaffective disorder, HTN, COPD, Chronic pain, and Covid + that presents today from Big Rapids with concern for acute ischemic stroke. To review, he was recently admitted with aspiration PNA 8/26/2021 and was discharged back to his AFC home and unfortunately requires more assistance then they can provide (requiring 2-3 person assist). He present to Big Rapids ER 9/9 and was admitted for evaluation by PT/OT for recommendations for rehab/placement. He had complaints of cough, nasal drainage, and sore throat. Covid testing was negative 9/8 and repeated on admission which was positive, however, he remains stable on room air with plans for monoclonal antibody treatment. Last evening he was LKW at 2230, upon reevaluation he had acute onset right facial droop, RUE/RLE plegia, and dysarthria at 0044. A stroke code was initiated, 24, BP 142/67. A head CT was negative for acute hemorrhage yet revealed a new acute/subacute lacunar infarct at the left thalamus and small left cerebellar infarct, since 11/7/2020), CTA was significantly degraded by motion vessels visualized were negative for LVO, CTP with no hypoperfusion or core. Accordingly, TPA was administered at 0217 and the patient was transferred to SHBW NICU for further evaluation. Upon arrival to the NICU he was drowsy and dysarthric, followed simple commands. His strength appears generalized, minimally worse on right. Will complete a stroke workup and follow his Covid for potential respiratory compromise. ROS was difficult secondary to dysarthria, he denied chest pain, abdominal pain. Unable to obtain complaints due to dysarthria.  Note from 9.16.21:  ASSESSMENT / PLAN * Acute ischemic stroke (HCC) Assessment & Plan Stable  CT head in Big Rapids showed acute/subacute lacunar infarct at the left thalamus and a small left cerebellar infarction. tPA given with no complications with some improvement of symptoms. Unable to perform MRI brain due to implanted low back stmuilator. Repeat CTHs have been stable with no evidence of bleed or new infarcts. ECHO normal.            -continue statin           -PT/OT/SLP consulted; recommend SAR and dysphagia diet           -normal BP goal           -discharge planned to subacute rehab   COVID-19 Assessment & Plan Improving.  Current oxygen requirement: SpO2: 92 % O2 Flow Rate (l/min): 2 l/min, Lymphocyte count: 0.75, CRP: 28.5, D-dimer: No results found for requested labs within last 720 hours., Ferritin: No results found for requested labs within last 720 hours., Procalcitonin: 0.07  -Dexamethasone 6 mg day 6 -VTE prophylaxis with enoxaparin -Escalating oxygen support up to and including intubation
I noticed pain in my lower back and front thigh area. I was achy with muscle pain. I developed a bronchitis like cough. When I woke up that Saturday morning I completed a home test and was positive. I treated myself with Advil and Tylenol and plenty of fluids. Coughing made it hard to get a good nights re st so I contacted my doctor and she prescribed Benzonatate 200 mg to take 3 times a day. That helped because by that Wednesday I was feeling better. I have a slight cough but I believe I have completely recovered.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T010313 has been verified to be valid, expiration date reported and established as 24-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. It was reported that the vaccine was exposed to the following previous temperature excursions: 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 F) for 1 hour, 14 Fahrenheit degrees to 46 Fahrenheit degrees (32.36 F) for 1 hour and 14 Fahrenheit degrees to 46 Fahrenheit degrees (21.38 F) for 37 minutes. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Case number PHEH2015US026972, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 43 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
This spontaneous report as received from a medical assistant refers to 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 26-SEP-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:Original Case : 1610USA004609.
Mixing error occurred, patient may have received only diluent. Pt scheduled to be revaccinated 05/07/21
the patient has Covid-19; the patient has Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "the patient has Covid-19".  Additional information: Reporter asked if the patient has Covid-19, how long before they would be able to get the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Patient expericed slight tightening of throat/tingling. But was able to swallow. He was asked to take Benadryl but he refused and was given loratadine 10mg tab (1) by mouth. He was observed for 30 minutes and a was driven home. A follow up was conducted 4 hours later he was fine.
The patient received recombinant zoster vaccine (RZV) 0.5 ml IM in Left    deltoid.     Manufacturer: GlaxoSmithKline     Lot#s and Expiration Date: Vial#1-J2N44 Exp-05/17/2022 Vial#2-7TB74     Exp-05/17/2022     Complications: None   at time of the injections. ON NOV22 (plus or minus) patient experienced ear pain and pressure, called nursing triage on November 24 reporting ear pain and ear pressure, numb lips, jaw numbness and drooling and was found to have left lower facial muscle weakness diag w/left sided Bells Palsy
On 5-6-10, 2" X 2" red rash at injection site, mild, swelling and warm to touch.  Low grade fever.
10/15 Reports receiving Pfizer booster PAA1 73398 in left arm and reports immediate adverse  Effects:  Immediately after injection : patient reported feeling  ?Dizzy and nauseous and generally unwell?, reports diarrhea that began in eve and Persisted for 3 days  10/16 reported waking with 6/10 chest pain and  Tightness and heart palpitations. Also reported development of profuse pebbly red rash  10/17 patient reported waking with cervical swelling from c5- T3 And 7/10 cervical pain that increased with lateral cervical Rotation . Reports pain radiated to upper trapezius and  Into anterior scalenes bilaterally . Reports palpitations and  Chest pain subsided 10/20 - patient reported 5/10 breast pain and tenderness  As well as spotting between menses. Patient reports she has Never experienced spotting between cycles prior to this event 10/22 - patient reports developing systemic raised  Rashes in umbilicus, groin, medial aspect of knees and elbows Reports rash is ?itchy and the irritation increases In the afternoon and evenings ? . Patient denies change  Of detergents, clothing or hiking in woody environments  Within 1 week of developing rashes. 10/29 - Patient sought acupuncture treatment and reports  Cervical pain Is still present - 4//10 - worse w/ lateral rotation But denies presence of radicular pain . Upon examination,  C5-T3 appears swollen and slightly warm to the touch Examination of rashes reveal raised patches with exudate Inside of knees, elbows and at umbilicus.
Bloody diarrhea tested poop for answers then the test were negative and then severe pain started with belly pain and was sent to another dr. then sent to the hospital for intussusception.
Initial case was received from a consumer on 14 November 2013. This female patent of unknown age whose medical history and concomitant medication was not reported had received an influenza vaccine (flu shot , batch number, dose, route and anatomical site of administration not reported) on 30 September 2013. On 08 November 2013 and on next day she "did not feel well" and went to emergency room. She ws experiencing "stomach issue". ON 11 November 2013, she was to start with teriflunomide (Aubagio) but, had not started because of warning about Aubagio that waiting period is about six months if they received certain vaccine before starting the teriflunomide. No corrective treatment or laboratory investigations were mentioned. The outcome of the event was unknown. The list of documents held by sender: none
This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.
Full Body Rash after 3 days severe at first then fading.  Now it comes and goes - itchy and red. Hair loss after a week.  Have lost at least 60%of hair at this point.  Continuing General Fatigue sever at first . Now is a constant less severe symtom Flash Headaches at fist. Now once in awhile Digestive issues - horrible constipation, ongoin
EMPLOYEE BECAME DIZZY 2 HOURS AFTER RECEIVING  HER FIRST VACCINE AND DIZZINESS LASTED APPROXIMATELY 4 HOURS.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Small rash at injection site that grew to about 1x1. Several itchy bumps that have shown up over the past 24-48 hours (approximately 8 bumps) may vaccine related or other reason. Visited primary doctor due to itchiness at injection site and other bumps itching. Doctor suggested watching for further symptoms and reporting back and taking OTC meds for now.