chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple medical conditions diagnosed since starting ANTHRAX vaccine series, including fatigue, reproducible arthralgias / myalgias, and obstructive lung disease Joint pain, multiple joints Start: 01/22/1999 back, knees, R shoulder, feet  Symptom: Fatigue, Malaise >60 Days Start: 01/22/1999 Symptom: Muscle Pain Start: 01/22/1999 Symptom: Dyspnea on exertion Start: 01/22/1999 Symptom: Erectile dysfunction Start: 01/22/1999 Symptom: Decreased libido (sexual drive) Start: 01/22/1999 Symptom: Dizziness Start: 01/22/1999 Symptom: Paresthesia Start: 01/22/1999 Symptom: Rash, focal Start: 09/08/2003 Comment: shingles Symptom: Dysphagia Start: 08/12/2002 Comment: heartbum Symptom: Chest Pain Start: 02/27/2002 Comment: atypical   6/17/09 Medical records received DOS 08/01 to 6/23/05. Patient presented with following problems related to the adverse event: cervicalgia, inhibited sexual excitement, Asthma, extrinsic w/o status asthmaticus, lumbago, chondromalacia patella, syndrome rotator cuff shoulder. The records provide a summary of services related to adverse event.
sx have been ongoing since 5AUG95 & have not resolved;c/o severe joint pain/swelling, chest pain, dizziness, nausea, optical sxs such as eye pain;saw family MD;c/o severe fatigue & excessive swelling
Four days after my Moderna COVID booster shot, I began to experience symptoms similar to POTS.  The problem started on November 27 with nausea, bloating, fatigue and lightheadedness after yardwork that involved a lot of stooping and standing back up.  On December 11, I ended up in the emergency room and Hospital. when my resting blood pressure was 170/120 due to severe nausea   Blood testing and an EKG did not show issues with my heart.  I had a follow-up appointment with Dr. on December 13.  I had an ultrasound to check my gall bladder, but it was clear.  I started Cipro on December 17 which helped with bloating and some with the nausea.  The POTS symptoms continued to grow worse with time.  By December 26, my heart rate when standing was 140 compared to 65 lying down.  Simple tasks like goig to the bathroom resulted in severe dizziness and nausea.  I lost 15 pounds in one month.  Since this time, the POTS symptoms have improved.  Today, my heart rate when standing is 105 compared to 65 when lying down.  I've gained a couple of pounds back.  I have not driven an automobile since December 10th.
Slight swelling, discomfort in injection arm. Knot in arm pit of injected arm.
I was giving 2 month immunizations  & for unknown reasons, encluded the flu immunization. I not sure  how this happened.  No excuse.  There were no problems  noted because of the immunization on f/u visit other than the continued raspy breathing.  Patient was referred to a pediatrician for the breathing problem.
Erythematous 4cm annular area  on left deltoid, warm to touch, pruritic, tender pain 3/10.
Mild numbness on the left side of their chin and lip; Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine; Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPOAESTHESIA (Mild numbness on the left side of their chin and lip), VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Premature ventricular contractions.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 10-Mar-2021, the patient experienced HYPOAESTHESIA (Mild numbness on the left side of their chin and lip), VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. At the time of the report, HYPOAESTHESIA (Mild numbness on the left side of their chin and lip) had resolved, VENTRICULAR EXTRASYSTOLES (Pulmonary Ventricular Contractions (PVCs) that increased after the vaccine) had not resolved and HYPOAESTHESIA (Painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,jaw and ear) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-052750 (Patient Link).
Itchy head, which progressed to other parts of the body in the following days; Bumps all over body; Some discomfort with breathing when taking a deep breath; This is a spontaneous report from a contactable consumer (relative). A female patient of an unspecified age (reported as "Pt age: 25", unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Dec2020, patient experienced itchy head, which progressed to other parts of the body in the following days. The patient also experienced bumps all over body and some discomfort with breathing when taking a deep breath. Outcome of the events was not recovered (reported as "ongoing").  Information on the lot/batch number has been requested.
requested medical records, but never received them; pt had a positive COVID test oon 11/22/21; per death certificate, pt died in the hospital with the cause of death being COVID 19
Information has been received from a consumer concerning her daughter a 15 year old patient with a history of dizzy spells during ovulation and no drug reactions/allergies, who in July 2009, was vaccinated with the first dose of GARDASIL (lot number not available). Concomitant therapy included an unspecified acne medication. In July 2009, the patient experienced weight loss, nausea, vomiting, fainting, dizziness, muscle weakness, heart arrhythmia, fatigue, stomach ache, headache and vision problems after receiving GARDASIL. The patient went to the emergency room but was not admitted to the hospital. Unspecified tests were done at the emergency room (results not provided). At the time of the report the patient had not recovered. The patient sought medical attention (physician, pharmacist). Follow up information has been received from the physician who reported that on 28-JUL-2009, prior to receiving GARDASIL the patient had complained of vomiting problems and difficulty sleeping and waking up. On 28-JUL-2009, the patient received the first dose of GARDASIL (lot number 663451/0216Y) and concomitantly received a booster dose of VARIVAX (Merck) (lot number 663323/0645Y). On 11-SEP-2009, the patient went to Urgent Care and complained of abdominal pain, vomiting and possible syncope. The patient had a cardiac work up with a Cardiologist (results not reported). The patient was transferred from the Cardiologist to a Pediatric Cardiologist. The Pediatric Cardiologist discontinued all cardiac medications. On 22-JAN-2010, the patient was seen by the physician. The patient reported to the physician that she had life threatening stomach problems. The physician stated that the patient was not terribly ill with life threatening stomach problems. The patient had a sedimentation rate test which was elevated. The physician stated that the patient had an appointment with a Gastroenterologist. Additional information has been requested.
Vaccine Leakage out of the arm after administration; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine leakage out of the arm after administration.   The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, during withdrawal of the needle from the muscle, the patient experienced vaccine leakage out of the arm after administration. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine leakage out of the arm after administration, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.
Sore body all over; Fatigued; Just felt unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 83-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Feb2021 at 16:00 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and diabetes. The patient was allergic to metropolis. Concomitant medications were not reported. The patient previously received niacin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021 at 06:00, the patient experienced sore body all over, fatigued, and just felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit and 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 sore body all over, fatigued and just felt unwell was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 13-FEB-2021, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 1) (suspension for injection, route of admin, batch number: 1805031, expiry: 21-JAN-2022), dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 1).  On 22-OCT-2021, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 2) (suspension for injection, route of admin, batch number: 1822811, expiry: 17-AUG-2022), dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 2).  On 03-JUN-2022, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, 1 total administered for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. Age at time of vaccination 60 years old. No concomitant medications were reported. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Local erythema and induration, maliase/ myalgia lasting 24 hours.
This spontaneous report was received from a nurse and refers to as many as 30 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. In July 2016 (reported as "between 05-JUL-2016 and 09-JUL-2016"), the patients were each administered improperly stored doses of VAQTA lot # M009377, expiration date 17-JUN-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 48 degrees Fahrenheit for 15 hours. Digital Data Logger was involved. There was no previous excursion. No adverse effects reported. Additional information has been requested.
Left deltoid with redness, warm to touch- 4 inch area- advised cool compress 4-5 times daily- Tylenol every 4 hours- to primary care physician if work. Per doctor.
Fever, chills ,sore arm and lymph nodes swollen in arm pit of left arm
nausea,h/a,ua-frequency;APAP-IV-NaCl
Patient vomited and fainted after vaccination within 20 minutes of vaccination Patient was checked out by EMS and referred to hospital, but patient refused and went home
Patient appeared to have a fluid filled sac under the injection site of the shingrix vaccine. Injection site appeared to be in deltoid, sac was in the bicep area. Patient did not report any serious pain, fever or malaise
Incorrect flu vaccine given to patient.  Patient given FluBlok for 18 and up only.  Patient is 15 years of age at time of vaccine.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate.
Beyond use date 07/01/2023 dispensed on 07/06/2023
She tore her ACL, Needing surgery; This is a spontaneous report from a contactable Pharmacist (Mother) via Pfizer-sponsored program COVAX US Support. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunization and the patient scheduled to receive her second vaccine on 25Apr2021, but last Thursday the patient tore her ACL and will be needing surgery on 30Apr2021. Concerned about possible side effects. Husband received Pfizer doses. Trying to determine what the patient should do for the daughter to prevent blood clotting like what happened with (withheld) patients. Outcome of event was unknown.~  Additional information required. ; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed. the case will be reassessed after additional information is received on the causal factor for the event such as incidents of trauma or accidents. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate
Chills, fever, sweats, coughing, loss of appetite, body aches, pain behind left ear, weight loss...
low grade fever, lethargy, body aches, chills.  symptoms started the day after receiving the injection and lasted 24hrs without residual symptoms.
Heart inflammation that wakes me up, difficult but able to breathe, lasts for about 10-20 minutes, tight feeling in chest, feels like food is stuck in my chest
Dizziness, next day extreme exhaustion, aches, next day unable to focus eyes, next day add extreme back/leg aches and to ER; blood, urine chest Xray normal. Discharged.  5 more days still back pain.
Immediately after vaccine administrations HPV9, MCV4, Tdap consecutively. Pt stated seizing for approx. 5-8 secs. Held pt, told dad to go get Dr., Dr. arrive on the scene pt already stopped seizing, but a little confused. No vomiting or irritation noticed. Pt layed down in bed on applied cold compress to the head.
I'm Nervous; First dose Moderna, second dose Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 intramuscular, administered in left arm near shoulder on 17Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose for didn't want to get the virus; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm near shoulder on 28Jan2021 (Batch/Lot Number: EL9269), at unspecified dose for didn't want to get the virus. Medical history includes cholesterol and thyroid. Concomitant medication included simvastatin taken for cholesterol from 2011; levothyroxine taken for thyroid from 2011. Patient had pneumonia vaccine about 5 years ago (2016) and arm swelled up for almost 6 months and was red, never received second pneumonia vaccine. She is not pregnant at vaccination time. The patient was nervous. Patient went to the doctor for a physical. She received first dose Moderna Vaccine and the second dose Pfizer Covid Vaccine. She didn't' know she received the Pfizer Covid Vaccine until she waited the first 15 minutes after the Pfizer Covid dose two was administered. Patient went to get a physical, took a blood test to see if had antibodies, there are none. She just found out there are no antibodies and stated she was nervous. Patient surprised got two different vaccinations. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.
(Vaccination was provided while the patient was in her automobile) Tachycardia. 4-5 Mins post-vaccination, the patient began to complain of a Rapid Heartbeat and a slightly uneasy feelingreclined patient in the car seat. I had 911 called after I identified no shortness of breath or other breathing issues. HR over the next 10-15 mins went from 115 to150 before medics arrived. Her was taken with a finger pulse ox/HR monitor. She was able to walk from car to ambulance and then put on a gurney. After transport to Hosp., the patient-reported to me today she went through 4-5  "episodes" of waving tachycardia before it altogether subsided. She felt recovered entirely today (3/3). The patient never lost conscious.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via an unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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.
About 2 minutes after vaccination patient was feeling light headed, pale, sweaty, clampy. It lasted about a minute or 2 then he stated that he was starting to feel better. He stayed in the store about 30 minutes ( or until he was comfortable leaving on his own).
Severe weakness, persistent headache, nausea, joint pain, congestion, tiredness lasting almost 3 days.
Symptoms began on 11/22/99 w/ burning on chest & back., both legs had numbness & tingling. Tx w/ Voltaren.
Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (she has COPD and has not used her rescue inhaler) and a rapid heart rate.
The patient has not identified any adverse effects, but the patient did not inform us that she had already been vaccinated with 1 dose of Pfizer before receiving the Johnson & Johnson vaccine.
Patient had malaise and discomfort. Today he developed shingle like spots on his belly and under his arm. He called saying he now has shingles.
It was reported that a female pt (twin A) received a MENOMUNE vaccination on 8/30/00. Reportedly, sometime after the vaccination, the pt developed vomiting, headache, dizziness and muscle aches for 3 days. Further information requested. F/UP report on 3/4/03: From add'l info received on 1/22/01, add'l responsible MD, PT and Lab info were provided. Reportedly, there were no other medications, illnesses at time of vax or pre-existing conditions. No further info was provided. This case is closed.