chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential blood clotting from skewed d-dimer test; Severe swollen arm; Asthma exacerbation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2022 10:00 (Lot number: FJ2614) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination patient was diagnosed with COVID-19. Concomitant medication(s) included: EFFEXOR; ALBUTEROL [SALBUTAMOL]; ALLEGRA D. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk9895, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 15Feb2022, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 09Mar2022 12:00, outcome "not recovered", described as "Potential blood clotting from skewed d-dimer test"; PERIPHERAL SWELLING (non-serious) with onset 09Mar2022 12:00, outcome "not recovered", described as "Severe swollen arm"; ASTHMA (non-serious) with onset 09Mar2022 12:00, outcome "not recovered", described as "Asthma exacerbation". The events "potential blood clotting from skewed d-dimer test", "severe swollen arm" and "asthma exacerbation" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: fibrin d dimer: (09Mar2022) potential blood clotting, notes: potential blood clotting from skewed d-dimer test. Therapeutic measures were taken as a result of thrombosis, peripheral swelling, asthma with anticoagulants, oral steroid, inhaled steroid.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was albuterol inhaler. Since the vaccination the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
MI with no obstructive arteries; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6955) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Has a lot of heart issues" (unspecified if ongoing); "has had MI's before" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ACUTE MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "MI with no obstructive arteries". The patient was hospitalized for acute myocardial infarction (start date: 2021, discharge date: 2021, hospitalization duration: 5 day(s)).  Clinical course: It was reported that, report is not related to a study or programme. The patient's medical history included a lot of heart issues, coronary artery disease, myocardial infarction and she was on concomitant medications including blood thinners and a couple of other heart related medications. No family medical history relevant to adverse events was reported. The patient did not receive other vaccine in four weeks of vaccination. After the patient had the first dose of the Covid vaccine, they called it an MI and she has had MI's before. It was reported as myocardial infarction (MI) with no obstructive arteries and had resulted in hospitalization for 5 days to an unspecified date in 2021 with an unknown outcome. The patient did not remember exact dates or time frame she was hospitalized, and no information was reported regarding the event resulted in for death, life-threatening, prolonged hospitalization, disabling/incapacitating or Congenital anomaly/birth defect. The patient reported she just called because she was angry at herself for receiving this vaccine and thought there are a lot of other people put there with far worse reactions than she had and patient was one of the lucky ones.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event acute myocardial infaction  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
27JAN98 sl formed & watery stool for 1 day;30JAN98 afternoon p/vax red papules in cluster or patches w/itching;pt applies cream to rash;rash over upper torso & back & both arms;
This spontaneous report as received from a healthcare worker (office manager) refers to a 4 year old patient of unknown gender. Information on patient's pertinent medical history was not provided. On 12-AUG-2016, the patient was vaccinated with PROQUAD (lot # M010477, expiry 01-SEP-2017) 0.5 ml, subcutaneous and 0.5ml of VARIVAX (lot # L021211, expiry 10-JUN-2017, route not reported) (Overdose was noted since both vaccine contains varicella virus vaccine live). No adverse effects were reported. No further information was provided. Additional information has been requested.
1.5 hrs p/vax painful swollen arm; cried 2 hrs, sent home from school; fever & swollen arm x 1 wk; unable to bend arm x 6 days;
Patient received 2 doses of Janssen product. No adverse events have been reported to the health department and contact information provided by patient is not working for re-connecting with the patient.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
evening p/vax had staring spell & jerking of amrs & legs ?duration, t101; past hx significant for neonatal storke & sz in neonatal period; pt on Phenobarbital; neurologist felt this was nonprogressive & that there was no contraindication to
I started to get a queasy stomach and foggy head like going to pass out. Felt like death. So I had to walk around. Also felt cold.
30 minutes after injection my throat began to close up. I couldn?t swallow. I wasn?t getting much air and talking was very difficult.   I live in a rural area and we were a distance from the vaccination site now (yes I waited the recommended 15 minutes) and didn?t have access to an epi pen.  I took my inhaler repeatedly until my throat relaxed and opened up.   After the initial reaction I continued to wheeze and need my inhaler A LOT for the next week.
Gave Prevnar-20 vaccine to patient instead of Gardasil-9 vaccine
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
Redness, hot, swelling around injection site 8 cm x 9 cm. Tingling and numbness of lips. Aching muscles. Shortness of breath.
Information regarding poliovirus vaccine was received from an attorney regarding a male pt who experienced mesothelioma and cancer. The pt received vaccine. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered between 1974 and 1977. Dose regimen was not provided. Concomitant medications were not reported. The attorney alleges that the decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, including but not limited to breathing difficulties, asbestosis, lung and/or other cancer (carcinoma NOS), mesothelioma, and/or other lung damage. Decedent died of esothelioma on 9/9/02. Decedent was diagnosed with mesothelioma on or about November 2002. No additional info was available at the time of this report.
Worst vertigo and nausea in my life, sweats and chills with it lasting 6 hours. Low energy for several days. 1 week later I feel good again.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose
neuralgia type pain lt side of face;had dull to sharp pain in upper jaw (lt side), cheek, lt sided of nasal passage up through lt forehead;also exp pain behind lt side of ear;to dentist, no relation to dental problem;pain cont x 10 days;
This was a series of 3 Gardasil shots given to on the following dates. 4/24/2014, 6/10/2014, 11/14/2014.  In Nov. 2018, patient started experiencing a stiff neck.  After a couple of weeks, she also had tingling in her left arm.  By Jan 2019, she experienced loss of vision in her left eye.  After being rushed to the ER we were told she had MS.  In January, 2019, she was diagnosed with Relapsing Remitting Multiple Sclerosis at the at of 17.  She will now have annual MRI's and Have infusions of Retuximab every 6 months for the rest of her life.
Large amount of redness and swelling in right arm 3 days after injection. DTaP given on 5-12-04. Fever in arm.
Pain in the shoulder joint.  Pain seemed to worsen over the week, became severe with limtd range of motion 2:00 am 4/17/16.
Patient brought to ED by parent who reported patient had period of apnea and cyanosis. PLEASE NOTE THAT I AM NOT COMPLETELY CERTAIN AS TO THE MANUFACTURER OR "TYPE" OF FLU VACCINE GIVEN BUT ACCORDING TO PARENTAL HX THE PATIENT DID RECEIVE FLU VACCINE 2 DAYS PRIOR TO EVENT BEING REPORTED
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments: US-009507513-2009USA006106:
shingles; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 26Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications was not reported. After 10 days of vaccination, on 07Mar2021, she broke out with the shingles. She wanted to know what to do about taking second dose. No treatment was given for the adverse event. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling, redness, and itching a few inches below the injection site began 20 hours after the injection.  A few hours later fatigue, chills, body aches, and headaches began. Symptoms to the arm persisted for several days, but other symptoms resolved within 24 hours.
10-23-08: Stiff neck, tingling of trigeminal nerve, sense of dread. 10-24-08: Increased tingling of face, all 4 extremities, trunk. ER visit 10-24. 10-27-08: Increase in symptoms, loss of sensation in a wave from mid shin, thigh and again up to waist. ER visit. 10-25-08 Admit to hospital, progressed to upper arm weakness. Extensive diagnostic work-up. IV SOLU-MEDROL x 3 days. Good response to steroids, remains with sensory dysathesias.  1/5/09-records received for DOS 10/24/08 and 10/28-10/31/08-DC DX: Possible vaccinal induced central nervous system postvaccinal autoimmune reaction. Presented with C/O multifocal dysesthesia and weakness. Postauricular pain, numbness, dizziness and left facial pain day prior. Electrical sharp shooting impulses down extremities mainly right side. Fully retained reflexes. IV steroid therapy. Developed respiratory distress, dysnpena and chest tightness. Ventricular tachycardia.
Stomach ache, weakness, body aches and pains - felt like the stomach flu, but no diarrhea or vomiting or fever.
After 1st dose :  Fatigue/tiredness/lack of energy for 1 day.  After 2nd dose: Fever of  101 - 102.6 for 3 days. Hips achy.  I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff.  The knee surgery was 3 years ago.  I was prescribed MOBIC for the knee by my surgeon when I reported the issue.
Injected arm feels like having a knot. It is warm, hot to the touch; like when you are getting sick; scratchy feeling in throat, throat felt weird; dry cough a little bit; sore throat; throat felt weird; Injected arm feels like having a knot; thumb sore in the joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit) and OROPHARYNGEAL PAIN (sore throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit), OROPHARYNGEAL PAIN (sore throat), OROPHARYNGEAL DISCOMFORT (throat felt weird), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint). On 10-Aug-2021, THROAT IRRITATION (scratchy feeling in throat, throat felt weird), OROPHARYNGEAL PAIN (sore throat) and OROPHARYNGEAL DISCOMFORT (throat felt weird) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), COUGH (dry cough a little bit), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Cholesterol medication. No treatment medications were provided.
Symptoms: Redness at injection site.   On left thigh Treatment: Administered 2.5ml of 12.5/5ml PO in office.
Narrative: Patient received two vaccines. PMH includes mixed dyslipidemia, diabetes mellitus, obstructive sleep apnea on CPAP, prior lung malingnacy, and in sinuc tach. admitted to outside hospital for chest pain and SOB. Patient died the following day. Unclear of any further details related to death. Reporting per facility instruction.
This spontaneous report as received from a other health professional refers to a unspecified patients of unknown demography. On 11-AUG-2015, the patients was vaccinated with 4 doses of improperly stored PROQUAD (Merck) (dose, route and frequency were not reported) lot # K011311. No adverse experiences reported. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
diarrhea; 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 patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "colon cancer surgery" (unspecified if ongoing), notes: she had a colon cancer surgery a month ago before she took the 1st dose. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2021, outcome "unknown", described as "diarrhea".  Additional information: Patient was due to take her 2nd dose of vaccine today 07Apr2021 at 2:30 pm and was having some diarrhea this morning (07Apr2021). She wanted to take an antidiarrheal medication, loperamide (IMODIUM) prior to receiving the 2nd dose vaccine and was asking if it was okay/safe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Sunday April 25th 2021, I woke up with severe chest pain that went up to the right side of my neck, as well as having shortness of breath.  I was admitted into the ER and they ran blood work, did a CT scan and x ray of My chest. When my bloodwork came back, it showed I had very elevated troponin levels. Because I was having continuous pain, I was given morphine but it didn't work. So they upped it and gave me dilaudid and that took the pain away. It was in the doctors best interest I get transported to a facility with a good cardiatric team. Upon arriving to the new facility, they further drew my blood and ran more tests. I got admitted as an in patient on the cardiatric floor. The cardiologists ordered for me to have an echocardiogram done, another CT scan with a special protocol to view my heart, and an MRI done of my heart.   After my echocardiogram and CT scan came back fine, the doctors said they'd be surprised if the MRI DIDNT show something. When that result came back, it did reveal my heart was still inflamed.   After ruling out all other possibilities they concluded that the 2nd Dose of Moderna COVID vaccination I'd received was the culprit behind my diagnosis. My diagnosis being, a case of myocarditis as well as a mild heart arrhythmia.   For the next several months I am kn a medication called metoprolol 25mg, 2 half tablets a day, to correct my heart arrhythmia and relieve stress from my heart as well as minimize the amount of stress I encounter each day. No heavy lifting pushing or pulling of any sort for the next 3 months.
Lethargic, temperature that lasted 3 hours after injection, muscle pains in arms and legs, confusion that has continually lasted, disorganized thoughts and delusional thinking.  Sought treatment from Dr. for medical evaluation and treatment.
Persistent headache that wouldn't go away after taking over the counter (generic Sudafed, not the PE version), acetaminophen and Ibuprofen - these last two were taken a couple hours apart. Also, chills and fatigue.
Information has been received from a nurse practitioner concerning a 53-year-old female who on 18-OCT-2007 was vaccinated subcutaneous with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # /1335U) instead of zoster vaccine live (Oka/Merck). The NP stated this occurred due to medical error not product confusion. No adverse experience occurred due to the event. A product quality complaint was not involved. Additional information has been requested.
Received vaccine on 10th. On the 13th noticed arm was itchy and red like sunburn. Spread about 4 inches beyond injection site. Used cold packs for treatment and anti bacterial cream  x 1 on Sunday night. Taking Tylenol BID
Body aches, headache, fever, chills, fatigue,  lasted about 8 hours. Did not improve with OTC NSAIDS.
1) Headache and fever - 3 days 2) Sweats and chills - 3 days 3) Sore arm and swelling - 14+ days
Pt received 1st dose at 345 pm at 355 pm, pt became diaphoretic and had tonic-clonic-like seizure, pt was lowered to the ground and seizure-like activity which lasted for a total of 5 -6 seconds. pt was then responsive without confusion. BP 110/70 T 96.9 O2 99% 4 L NC RR 18  HR 78 Vitals recheck at 410 BP 112/72 T 97.1 O2 100% RA RR 16 HR 74  Pt stated he had not eaten all day, he was given juice and granola bar. Pt reported feeling much improved. He was cleared to leave site at 430 and he will follow up with Urgent Care or PCP
vaccine to splash back on her face and in her eyes, no AE; during administering Hib vaccine and the needle and syringe came apart after injecting, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient (age not reported) who while injecting the vaccine HAEMOPHILUS TYPE B (HIB) VACCINE the needle and syringe came apart after injecting and caused some of the vaccine to splash back on her face and in her eyes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of occupational exposure to product and syringe issue.  It was reported that she immediately flushed her eyes with water and is not having any eye discomfort or vision problem.  At the time of report, no adverse event was reported.  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.  Information on the batch number was requested.
Pediatric patient was given a BOOSTRIX vaccine on 4/20/17 that expired 4/18/17. Patient and parent notified.
received the first dose of the pfizer covid 19 vaccine and then got covid 7-8 days after; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient received the first dose of the pfizer covid 19 vaccine and then got COVID 7-8 days after on an unspecified date. He and his wife received a viral cocktail. The caller wanted to know if it is recommended to wait 90 days for the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on got COVID 7-8 days after. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up attempts are completed. No further information is expected.
Began with a sore arm at injection site then could not lift arm higher than four inches without excruciating pain, muscles throughout body began to tense up and hurt, joints and hips ached and hurt, headache all over the top of my head, sweat then chills, tired, light headed, nauseated, temperature topping 103 degrees
My son had a headache and began running a fever at school and was at 101.7 when he came home. The fever increased overnight peaking at 102.8. The fever broke approx. 12/13 hours after onset.
Diagnosed with HSV 2 two years prior with only 1 initial outbreak. After first shot of vaccine, consistent HSV2 outbreak while on anti viral meds.