chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive; tested positive; This is a spontaneous report from a Program from a non-contactable consumer, reported similar events for two patients. This is the first of two reports. A patient (consumer) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's friend was tested positive even after having the 2 doses of the vaccine. Patient was just calling to ask about the booster shot if it was the same as the 1st 2 doses as patient was also tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300598 same reporter/drug/event, different patient.
TIA; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) revealed a stroke which was a TIA..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. Concomitant medications included diabetic medication, high blood pressure medication and heart disease medication.  Company Comment: This case concerns a 71-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of transient ischaemic attack. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up document contains updated patient demographics, suspect product details, events and narrative.; Sender's Comments: This case concerns a 71-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of transient ischaemic attack. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
He is getting very high fevers, like 105, 106. Every 6 hours basically; it's been occurring very high fever consistent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 6-year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer unknown), for COVID-19 Immunization. The following information was reported PYREXIA (medically significant) with onset Dec2021, outcome not recovered. Reporter stated, the patient got the Pfizer vaccine second dose, last Friday and right afterwards he was getting very high fever, like 105, 106. Every 6 hours basically, initially, you know of course after vaccine it can happen 48 hours maybe, but it had been occurring, very high fever consistent. So, they wanted to make sure if you guys have been hearing this because they got check for infection and everything is negative. But have you had this long high fevers with the children. The patient underwent the following laboratory tests and procedure: body temperature: (Dec2021) 105; (Dec2021) 106; investigation (got check for infection): (Dec2021) negative.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA; fatigue the next day, pain at the injection site and down the arm. No redness at the injection point, swollen lymph nodes on the injection arm side - in the armpit for 4 days after.
Information has been received from a pharmacist concerning a female patient of unknown age who in February 2005, was vaccinated with a first dose of PNEUMOVAX 23. On 19-FEB-2010 the patient was vaccinated with a second dose of PNEUMOVAX 23. Concomitant therapy included NEXIUM, XANAX and levothyroxine Na. On 20-FEB-2010 the patient developed redness and a warming sensation extending about 4 inches around the injection site. No laboratories studies performed. At the time of this report the patient had not recovered from redness and a warming sensation extending about 4 inches around the injection site. Additional information has been requested.
Pt collapsed 1 day p/booster dose TTOX; taken to hosp by ambulance; @ hosp blood glucose measured 68 & 69 mg/dL; pt c/o being unable to see & repeated phone no; taken to ICU; 17JAN92 appeared confused, agitated, incoherent, encephalopathic
I had an inflammation right side lymph node. These is still there as of today. I went to doctor about this. They did an ultrasound and we are watching it and hoping it will go away.
7/1/2022 Received COVID booster. Shearing cold pain across clavicle, through joint, down arm upon injection. Injection was placed 1? below shoulder. Pain immediately radiated to clavicle. Unable to sleep due to high pain level; since then, unable to dress myself, brush my own hair or teeth. Diagnosed with frozen shoulder, remain in PT as of 10/14/2022.  Migraine Started morning of 7/2/2022. Have experienced migraine every day since.  Ongoing issues encountered: Tremors, pain to neck/back of head, confusion, hallucinations, slurred/slow speech, Parkinson?s-like symptoms (significant major tremors throughout body), nausea, chest pressure, shortness of breath, spikes in blood pressure. I have fallen three times, two ER visits, one for dizziness/head pain and the second for chest pressure and significant sudden blood pressure elevation (188/114).  Was terminated from new job due to inability to perform nursing job related to the response/reaction I am having.
This spontaneous report was received from a Registered nurse regarding 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
I got very sick. Vomiting, aches, pains and flu like symptoms. No cough. Did have fever I am still extremely tired and have been since getting the shot. Along with getting headaches almost every day
10/5/11 patient felt pain in arm and shoulder. Pain moved down arm. Later in day pain moved from arm into her neck, her neck & back now have "pain & tightness".
He started breaking out with a rash, it was spreading; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He started breaking out with a rash, it was spreading) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (He started breaking out with a rash, it was spreading). At the time of the report, RASH (He started breaking out with a rash, it was spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Oral allergic reaction. Tingling on lips and roof of mouth 8 minutes after vaccination VS 160/90  HR 91 SPO2 96% on room air; RR 16 Received Benadryl 50mg capsule at 9:08 am
I started feeling pain, burning,  in my left arm pit the night of the vaccination. The pain decreased  next couple of nights until last night when it woke me up with severe intensity and burning pain.  I have been struggling with this all day long.
Right hip pain, Left ankle pain, persistent since day  after vaccination, worse with walking  and not present at rest. Has not improved with time.
shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around November 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around April 2018, the pt was diagnosed with shingles by her primary care physician at the hospital. The event of shingles lasted for several months causing severe pain and suffering and difficulty with weakness for which she had to undergo physical therapy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. The outcome of the event of shingles was considered as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   The event of shingles was considered to be disabling.
He developed chest tightness, pressure, shortness of breath and chest fullness.  His chest discomfort was described as tightness and a full feeling.  His shortness of breath was worse at night when he felt that he had to consciously breath rather than it being an effortless unconscious process.  He saw a pulmonologist-not responsive to antibiotics and bronchodilators.  He had a normal CXR and a normal CT scan of chest without contrast.  His pulmonary function tests were OK.  Pulmonologist sent him to a cardiologist.  He had an echocardiogram which was consistent with myocarditis, His pericardium was OK.  It took an additions 3 weeks to get a cardiac MRI.  His symptoms resolved during that period and his MR was normal.
She got her vaccine, had a little bit of tenderness in her arm within 5 hours.  She didn't feel great but not horrible, just a little weird.  She went to bed, woke up with a headache, soreness in her arm.  The headache is frontal pressure and her head feels like her brain is swollen.   She has been taking Tylenol which did not help, and has been taking Advil which is helping some, but she goes to bed with a headache and wakes up with a headache.  She also started coughing a little bit yesterday and also continues today, just like a tickle.  She feels a pressure in her head.   She typically does not have constant headaches.
This spontaneous report was received from a consumer, via a company representative, referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patient was vaccinated with two doses of GARDASIL (dose number, route, frequency, lot/batch numbers and expiration dates were not reported) and, when he was 25 year old, one dose of GARDASIL 9 for prophylaxis (dose number, route, frequency, lot/batch numbers and expiration dates were not reported). The patient was seen by physician, on an unspecified date, because the patient developed, on an unknown date, "a genital wart on the end of his penis" (penile wart). The outcome of penile wart was not reported. The relationship between penile wart with GARDASIL 9 and GARDASIL was not stated. There was no product quality complaint (PQC) involved. Additional information has been requested.
Developed general weakness, occational productive cough, diarrhea, and anorexia starting on 03/20/2021. Tested positive for COVID-19 on 03/25/2021.
Fever; Nausea; Headache; Fainted twice this morning; This is a spontaneous report from a contactable consumer. This consumer reported events for both herself and her daughter. This case refers to reporter's daughter.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. On 01Aug2021, patient experienced fainted twice this morning , fever, nausea , headache .   In the place where patient had vaccine, they only say to take Tylenol (treatment), or to go to emergency room.  The mother does not want to go there. She is wondering if she can skip the second dose as she does not want to put in danger her daughter's life. The patient underwent lab tests which included antibody test for COVID-19 on unknown date and she has really good antibodies. Outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
1 of 3 pts immunized from the same vial who devel inject site reaction; pt vaxed 7JAN92 & 9JAN devel area of tenderness, erythema & warmth from inject site to elbow; felt to be cellulitis;
she presented numbness on her leg. Now she has numbness on her other leg.; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a female patient of an unspecified age that patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported), via an unspecified route, on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Pharmacist stated that a female patient is meant to receive the second dose of the Pfizer Covid-19 vaccine and the patient stated that two days after she received the first dose she presented numbness on her leg. Now she has numbness on her other leg. She would like to know if there are any reports on this side effect. The outcome of event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolemia.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) had not resolved.            The patient was given steroids as treatment medication.  The patient was on blood pressure and cholesterol medicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain. Pressure both lower legs (calf) and behind knees: helped by resting (in recliner). Makes worse: walking.
This case was reported by a consumer via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and myalgia upper extremities. On an unknown date, the outcome of the fever and myalgia upper extremities were unknown. It was unknown if the reporter considered the fever and myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine, more than one month before the date of reporting. The patient did have a fever the first few days. However, the patient still had horrible muscle soreness in arms and shoulders, bilaterally, at the time of reporting. The patient asked what she could do about this and whether it was ok to have the second dose.
Discovered after the fact that the person was under the age of 18 yrs. Observed as per protocol and no issues. Hot wash held after clinic to determine what went wrong and protocols already in place tightened.
Rash in the injection location, lasted for a couple of minutes Slight headache, no medication taken
The patient had a fever for two days maximum 102.8, 4 days after immunization. Rash on trunk following fever, and constipation following the rash.
This isn't an adverse event , but an administration error.  The patient initially received too small a dose of Moderna COVID-19 booster vaccine. The correct dose (0.25ml) was then administered to patient.
Initial unsolicited report received from literature on 18 June 2015. This case is linked to 2015SA090249, 2015SA090257, 2015SA090259, 2015SA090260, 2015SA090261 and 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Three female patient, whose medical history and concomitant medications were not reported, had received a dose of IIV3 or Trivalent Inactivated Influenza Vaccine (batch number, route and site of administration were not reported) and also received a dose of H1N1 (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, after vaccination, three patients experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
COVID 19/ tested positive for Covid again; COVID 19/ tested positive for Covid again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox"; Amitryptaline, reaction(s): "Known allergies: amitryptaline", notes: amitryptaline.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19/ tested positive for Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received treatment with Paxlovid Pfizer, date of start of drug: 03May2022, date of last administration: 08May2022. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Five days after completion of the 5-day course of Paxlovid for treatment of Covid (and feeling well for 4 days), she developed symptoms (headache, sneezing, head congestion, lethargy) and tested positive for Covid again. She received treatment for those adverse events with OTC medications to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Signs and symptoms of Orthostatic intolerance, new (not happened before) Sinus tachycardia with sinus arrhythmia - confirmed, new (not happened before) Signs and symptoms of Postural orthostatic tachycardia syndrome (not happened before) Exertional dyspnea Tachycardia associated with ordinary and routine activities Hypovolemia Acute renal insufficiency  (never happened before)
Pt. was reported to have 'turned blue' was seen at ER. Possible seizures. Pt transferred to hospital per private vehicle with 'seizure like' activity. Reported by grandmother, that the patient had 'some sort of virus'. She also reported that he had 'a reaction to some sort of medication' that was given at the hospital. Also states he had a seizure while there and team 'checked him for an infection in the brain'