chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced a blood clot; caused a stroke which killed her.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Booster: 1), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, Primary series of vaccination completed), for Covid-19 Immunization. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "she experienced a blood clot"; CEREBROVASCULAR ACCIDENT (death, medically significant), outcome "fatal", described as "caused a stroke which killed her.". The patient underwent the following laboratory tests and procedures: Body mass index: Low, notes: a low bmi. The patient date of death was unknown. Reported cause of death: "caused a stroke which killed her.", "she experienced a blood clot". It was not reported if an autopsy was performed.  Clinical course: Reporter mother was a healthy woman who maintained a low bmi and a healthy vegetable focused diet. However, 4 days after second booster patient experienced a blood clot which caused a stroke which killed her. Reporter was interested in getting pfizer data on the situation if it can help to improve vaccination efficacy and reduce side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: caused a stroke which killed her.; she experienced a blood clot
PT WAS SHAKING AND FAINTED (NOT SEEN BY PHARMACIST) PT WAS PALE AND FELT SWEATY. ASKED PT TO SIT DOWN AND GIVEN WATER. PT FELT FINE AFTER 15 MINUTES AND LEFT WITH WIFE. STATING HE WAS ANXIOUS ABOUT VACCINE. PT DENIED SEEKING MEDICAL PERSONNEL.
Almost immediately after getting the vaccine I had throat closure, respiratory distress, and itchiness from my head to my toes. It felt like I had burning ants traveling through my body. I also had irregular heartbeat. My heart rate sped up. Within a couple hours when I was able to talk and I was feeling better I started calling my doctor to set up an appointment but I have not received an answer. My pharmacist recommended to not take the second dose due to my reaction.  I have only been taking  vitamins and my inhaler that I use daily.
Starting around 15:00 Patient had an event following within 5 minutes of administration of the influenza vaccination. She endorses feeling dizzy followed by shaking and a brief period of unresponsiveness. Her heart rate was regular and a rate between 50-60. Her BP fell from 115/70 to 80/60. She developed diaphoresis. She become responsive but acted confused for around 1-2 minutes. She returned to baseline by 15:15 ***
Hives within 45 minutes of injection. Feeling unwell overall. Approximately 52 hours after injection it felt like throat was tightening/closing up .
about 4 hours post-injection, pain began in neck and shoulder accompanied by a severe headache.  A couple hours later pain radiating down arm and numbness/tingling in fingers.Next day--neck, front and back of shoulder in severe pain.  Mobility and range of motion extremely limited.  Pain and symptoms continuing at present.
Severe headache, weakness, nausea, diarrhea, dizziness, shaky.
Light-headedness, dizziness, headache.  Feelings of being cold/hot with high lability.  Facial pressure.  Exacerbating throughout the day and continuing into the following day.
Medication Stored Outside of Recommended Temperature Excursion Ranges Was Administered to Patient; Initial Report Received on 20-Dec-2019  A Nurse called and reported that a male patient received HEPLISAV-B that was stored outside of the recommended temperature range.  The patient has had a blood pressure of 131/78 at the time of vaccination with HEPLISAV-B.    Medical history reported included hypertension that had not been diagnosed and for which he does not take medication.    The patient had no medication history.   On 19-Dec-2019, the patient was vaccinated with his first dose of HEPLISAV-B (Lot # 933842, expiration 30 May 2021, Box Serial # 277427890985) that was determined to have been stored outside of the recommended range (maximum 16 degrees Celsius for 65 hours) for a temperature excursion.     On 19-Dec-2019, at the time of vaccination, the patient's blood pressure was taken and was noted to be 131/78.   At the time of the report, the patient had not been informed and there were no adverse reactions reported.   No additional information was provided.    Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI and IB.
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # L038669, expiration date 11-AUG-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Soreness, aching and decreased range of motion post vaccine administration on 9/28/15.
This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received unknown dose on an unknow date).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had missing vaccination schedule regarding Infanrix.The reporter did not know how many doses were missing. Till the time of reporting, the patient did not receive remaining dose of Infanrix, which led to incomplete course of vaccination. The reporter wanted to proceed with Boostrix and asked which would it be the best option to proceed with vaccination schedule. The reporter did not consent to follow up.
PT COMPLAINS OF "HEMATOMA".  AS PER OUR CONVERSATION, AREA IS SWOLLEN AND WARM TO TOUCH.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient 's age was reported as 80 year 3 months.  No concomitant medications were reported.  It was reported that patients at facility that received this moderna vaccine between  08-Apr-2022 to 15-Dec-2022    No treatment information was provided.
ill; getting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (2023-2024 formula) (Dose Number Unknown, Single, The first 2 shots we got were Covid and Flu on 02Oct), administration date: 02Oct2023, for COVID-19 Immunization, reaction(s): "COVID-19"; flu shot (The first 2 shots we got were Covid and Flu on 02Oct), administration date: 02Oct2023, for Immunization. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "getting Covid"; ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "ill".  Additional information: The patient had COVID vaccine and flu shot on 02Oct2023. Then had RSV vaccine on 23Oct2023 for which the patient felt ill and wound up getting COVID.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Right eye itchy - swelling under right eye - went to eye doctor. Eye drops - warm compresses.
Pneumovax 23, lot L031459 (0.5mg) causing Joint pain, hands, wrists, shoulders, knees, dizziness, blurred vision.  Went to Urgent Care, Dr. prescribed Meloxicam, 25 mg.
I woke up the morning following the vaccination with a slight fever, a very loud beeping in both ears consistent with my pulse rate, and a pulse of 115 (normally it's 66). Around noon I went back to the pharmacy to ask whether an elevated heart rate was a known side effect. The pharmacist verified my HR and sent me home warning me to look out for symptoms of a stroke. I decided instead to go to Urgent Care where they verified my tachycardia, took an Xray to check my lungs (they were normal) and an EKG (also normal). They sent me home warning me to look out for symptoms of a stroke. I woke up the next morning with a normal heart rate and almost inaudible tinnitus  (normal for me). Three days after the tachycardia I was examined by a physician whose comment was "thank goodness this was your second vaccination, not your first." She then entered Shingrix in my medical record as an allergy.
On 10/28 I had a routine fasting blood test as part of my wellness exam. I was not experiencing any unusual symptoms. But at that same time, I also had just started a statin medication three weeks prior to having the blood test. So that may have caused the event. The blood test showed a spike in my ALT to 151 and AST went to 58. Now historically, in August the ALT was 74. That's the highest it's ever been. Five months prior it was 47, and back to 60s & 70s. But I have never seen my ALT at 151. The AST was also high but not as high. My doctor ordered an ultrasound of the abdomen and included the whole region. The results, according to my interpretation, seems like my liver is fine. I'm not sure if it's a result of the vaccine or my medication, or even any other factors. If the indication of my ultrasound is correct, then I don't know what contributed to the reading. The range is 12-59 for ALT, and it was 151. The other ranges were a little high on the comprehensive metabolic panel, but doctor said I just needed to hydrate.
Pain at injection site; Nausea; Chills; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration on 27Oct2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Oct2021, the patient experienced nausea, chills and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills and pain at injection site was unknown at the time of this report.
Large red rash (12 X 5 inches); itching, headache, very fast heartbeat - could not sleep.
Headache, chills, and body aches. lasting 2 hours. Headache lasting 8 hours states "splitting" H.A.
11/29/2013 client expressed a "funny", "sinking into the floor" feeling in her leg. 11/30/13 still complained of this. Then per the client's mother she fell to the floor and had a seizure. Was taken by ambulance to the ER. This was client's right leg.
Fever of 102.4 within 14 hours of vaccine.  Runny nose, fever continued for several days.  On 02/04/2013 viral rash covering entire body and fever of 101 and required Emergency Room visit.  Rash was visible for one week.  Change in child's disposition.  Very irritable, sleep disturbances and crying.
Minor sore throat and tenderness in glands in throat , soreness in arm, headache, some chills and sweating, but no fever,  vomiting commence 11 pm til 3 a.m.
This spontaneous report as received from a male patient of unknown age, concerning himself. The patient reported that on an unknown date ("a few years ago") he had Shingles and got the ZOSTAVAX shot at that time (dose, route and lot # not reported). Recently he had a reoccurrence of Shingles and got ZOSTAVAX shot again (dose, route and lot # not reported) on 19-JUL-2012. The patient did not consult his primary care physician before getting the most recent shot, he just went directly to the pharmacy and had the injection. The patient stated that he is still experiencing Shingles symptoms. Additional information has been requested.
10/28/03 at 6:00 PM c/o right arm aching. 10/29/03 swelling began in right arm from injection to about wrist area. She stated it got a little red. She stated she pushed mowed the yard, which could aggravate it. She took Advil to relieve discomfort 10/29/03. 10/30/03 she called to report it to the health dept. Pt stated it is not as tight in elbow as was yesterday. Encouraged to apply cool compress. Also encouraged to contact physician if it gets worse. Pt stated she would call tomorrow to inform how symptoms are. 10/31/03 pt stated that arm is getting better. 11/3/03 called to check on pt. Stated arm is a lot better now. No further problems.
pt recv vax & w/in 24 hr post vax pt exp migraine h/a, ache in neck, ache in shoulder, numbness & tingling in unspecified arm, myalgia, arthralgia & nausea;tx APAP & Ibuprofen as needed;sx resolved w/in 48hr;
On 10/13/00, parent counted 58 lesions. Also had fever and runny nose. Nasal drainage was yellow to green in color. Doctor prescribed Amoxicillin for 10 days.
pt died 9FEB97;19 days p/vax;prior rxn-high temp 102 24hr w/in receiving shot;COD SIDS; APAP administered;
Started developing full-body hives without angioedema 10 days after the COVID vaccine, which has been ongoing.  Symptoms were red rash and itching all over body.  Recommended to start claritin/loratidine 10 mg po daily, and this has helped control the symptoms.  I only rarely experienced hives prior to this, usually self-limited within hours and only in response to certain foods (like if I ate too many carrots with the carrot greens).  I am still experiencing mild flares of hives every 1-2 days but it is very manageable with a daily claritin and is no longer significantly impacting my activities of daily living.  Today is day 16 since the symptoms began, and day 14 since I spoke with my PCP and started taking the claritin.
Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was given instead of 0.3mL. The prisoner had no adverse reaction or symptoms due to the dosing error.
Angina Narrative: Pt presented to the ED with persistent chest pain and shortness of breath for 6 days after receiving 2nd dose of covid vaccine. Symptoms began morning after receiving vaccine. Negative work up, however pt is high risk of cardiac events. Given ASA and nitro for ongoing chest pain that is possibly cardiac in nature. Pt admitted.
started with chest pain, worsening by morning, saw PCP who sent to ER for R/O myocarditis
I have been experiencing intense nausea and vomiting the day after  receiving the vaccine. Nothing has been able to treat the nausea.
fully vaccinated (2/20/21, 3/31/21).  developed symptoms on 7/17/21.  tested positive for covid-19
1st dose on 2022, didn´t received 2nd and 3rd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 28th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter stated that the patient did not receive the second and third dose after the first dose. The vaccine administration facility was the same as primary reporter. The healthcare professional did not give the details about the patient. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose.
Patient is a 78 y.o. male with past medical history of persistent AFib, diabetes, bladder cancer and prostate cancer s/p cystectomy with urostomy and prostatectomy, hyperlipidemia, CKD stage 3 who presented to the ED on 10/2 with complaints of fatigue, fevers, chills, dyspnea, productive cough, and nausea. Symptoms started about three days prior to presentation. Pt is fully vaccinated against COVID-19 with Moderna.   Upon arrival to the ED, patient was noted to be hypoxic requiring 2L of supplemental oxygen. He was also noted to be tachypneic and tachycardic. Labs were obtained and notable for Na-132, Cr-1.38, WBC-13.09, pro-bnp of 2471, troponins of 22 followed by 21. COVID PCR was positive. UA also showed evidence of possible infection. EKG demonstrated Afib with no acute ischemic changes. CXR demonstrated evidence of COVID PNA. Patient was given a dose of Decadron as well as Rocephin for possible UTI. He was then transferred to SH Blodgett for further care due to lack of bed availability.   Following admission, patient was continued on decadron and also started on remdesivir. He was diuresed to maintain net negative fluid balance. He was otherwise managed conservatively with improvement in his COVID symptoms. He was not felt to be a candidate for monoclonal Ab infusion given his initial hypoxia. Oxygen was able to be weaned to room air. Patient will discharge on oral decadron to complete 10 days of steroid therapy.   Patient was otherwise continued on Rocephin for possible UTI. Blood cultures and urine culture were obtained. 1/2 blood cultures drawn on 10/2 did return positive for Klebsiella pneumoniae. Repeat blood cultures obtained 10/3 remained NTD. Urine culture showed no growth of bacteria. Given bacteremia presumed to urinary source however, patient will discharge on ciprofloxacin to complete a 10-day course. He was discharged home in stable and improved condition
Some blood trickled down the arm; Mom is concerned that he may have not received the entire dose of the vaccine, because he is not complaining of much pain to injection site or arm; Mom is concerned that he may have not received the entire dose of the vaccine, because he is not complaining of much pain to injection site or arm; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Reporter was a mother of a 13-year-old who received the second shot of the Pfizer COVID vaccine and some blood trickled down the arm. Reporter was concerned that patient might have not received the entire dose of the vaccine, because he was not complaining of much pain to injection site or arm. The patient's mother reported events are non-serious. No product quality complains. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt recvd vax & had fever of 104 at 4am following am; told to get DT only; pt given apap; juice & sponged at home;
pt recv vax & exp fever of 103 & diarrhea;the next morning pt recovered;
tiredness; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix 50 µg. On 3rd June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 4th June 2019, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the wife of the patient. The patient received Shingrix and later that evening experienced redness and pain at the injection site. The reporter noted the area was 2 inches in diameter. The patient also experienced tiredness after about 24 hours. All issues resolved by the third day. The healthcare professional was not made aware of events per reporter.
When the pt went to get his 2nd shot he stated that approx 5 days prior his L arm was red, swollen, and bruised