chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within one week of receiving the first shot (10/24/2007), I experienced flu-like symptoms, fever, and such severe vaginal discomfort that I went to the emergency room. I was diagnosed with bacterial vaginosis. It cleared up, but my health felt off - worse digestion, I started getting heartburn, feeling fatigue, started seeing floaters in my vision and getting terrible headaches, and my menstrual cycle started becoming more irregular. I had always been like clockwork. I started losing weight, which was unusual, as I had always been overweight and had a hard time losing weight. I began feeling more and more irritable, but made no connections to the Gardasil shot. In March, immediately after receiving the second vaccine (3/17/08), my arm hurt terribly, I felt lightheaded, woozy, and had hives appear. Within 1 week, I started experiencing vaginal irritation again, fever, and had flu like symptoms. Over the course of the next month, I started to feel such severe fatigue, stomach aches, and uncontrollable diarrhea, that I went to my doctor. She told me I probably just had acid reflux. Two days later, I experience debilitating stomach pain, which lasted for nearly 1 month. I had an endoscopy, a CT scan, allergy tests, and blood work for thyroid disorders and other imbalances, all of which have come back reasonably normal and regular for my body and system. I did have some esophageal damage from acid reflux, and was put on Prevacid. Receiving no answers from the clinic, I cut out gluten, corn, soy, dairy, eggs, caffeine, alcohol, yeasts, and sugar from my diet and started working with an acupuncturist and naturopath. Stool sampling showed signs of Candida Yeast overgrowth in my intestines and parasites, which I am combating naturally with help from my naturopath, and managed to eliminate with diets and supplements after 9 months of treatment. I a got off the Prevacid successfully with her help, and am starting to feel stronger.   All total, after the vaccines, I experienced extreme weight loss (50 pounds),  hair loss, fatigue, eye itchiness, emotional upset, headaches, joint pain, tingling/numbness in hands and feet, lower body temperature, increasing food allergies/sensitivites, disruption in my sleep, decreased strength, muscle loss, continued gastrointestinal pain, alternating diarrhea/constipation, persistent Bacterial Vaginosis.  My energy is better and digestive issues have regulated, but I am on a very restrictive diet.  Em  I am still suffering amenorrhea and low hormone production, am easily fatigued, and still suffer occasional neurological issues.  All other labwork shows no sign of unusual health issues other than food allergies. 11/23/09 Medical records received for date 10/24/07 to 8/6/08. OV 10/24/07 Normal GYN exam. Pap smear WNL. All labs negative. Gardasil and Tdap vax given. OV 4/16/08 c/o diarrhea, weight loss, palpitations, irregular menses, DX: diarrhea, weight loss, palpitations, irregular menses. TSH WNL. OV 4/21/08 DX: back pain, abdominal pain. H-pylori(-). OV 8/6/08 c/o vaginal discharge with odor, itching. Assessment: (+)vaginal discharge w/ odor, wet prep(+), DX: vaginal leukorrhea
EXPIRED VACCINE IS ADMINISTERED DUE TO MISUNDERSTANDING WHEN STABLISHING THE EXPIRATION DATE IN THE database report.
Swollen lymph nodes; This is a spontaneous report received from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PF208ENG202), via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-type-2 diabetes mellitus, lupus and COVID-19. Concomitant medication included metformin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); both for unknown indications, from unknown dates. The patient previously took penicillin for unknown indication and experienced an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the reported event. The clinical outcome of the event swollen lymph nodes was not recovered.  No follow-up attempts are needed. No further information is expected.
Patients reports hard, internal lump at injection site, size of a baseball. Itchy. Did resolve to small lump, scabbed over.
The night of getting the shot I woke up in the night and I a fever of 100.5 degrees which lasted for about a week. I was very fatigued as well. I spent that week in bed and was just unwell. I had had the fatigue last up to this day. There has been a downturn in my general health since having had the vaccine.
Left thigh erythema 8cm x 5cm tenderness around inj site. Has full ROM.
Heart beating faster, heart pounding, and waking me up in the middle of the night. At least several nights. And Heart pounding as I'm sitting or laying down. This went on for 5 months or so. The fast beating and heart pounding out of my chest stopped in December and I feel normal today.
the first, second and third doses were administered to the patient on 10-DEC-2021, 08-FEB-2022 and 16-SEP-2022, respectively; the first, second and third doses were administered to the patient on 10-DEC-2021, 08-FEB-2022 and 16-SEP-2022, respectively; This spontaneous report was received from a nurse and refers to an 8-week-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. Patient histyorical vaccination included: diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5),tetanus vaccine toxoid (PENTACEL); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13); rotavirus vaccine live reassort oral 5v (ROTATEQ).   On 10-DEC-2021, the patient was vaccinated with dose 1 of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection; then second and third doses were administered to the patient on 08-FEB-2022 (Inappropriate schedule of vaccine administered) and 16-SEP-2022 (Inappropriate schedule of vaccine administered) respectively administered for prophylaxis (strengths, exact doses, lot #s, expiry dates, and routes of administration were not provided)   Other vaccination included: measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown) and varicella vaccine (manufacturer unknown).  This is one of 2 cases of the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA011004: US-009507513-2306USA013096:
CVA/Stroke: patient noticed loss of speech during conversation alerting the need for medical attention. Patient was treated inpatient at the local medical center. Patient has partially recovered has difficulty with speech in stressful situations and paralysis on left side of his face.
Redness, swelling injection site warmth, warm to touch. temp 101, tenderness and pain to touch at DTaP site.
After both vaccines, I had rapid heartbeat.  The 1st vaccine it lasted about a week on and off.  The 2nd week it started the night of the vaccine and lasted for roughly 2 weeks.  Even laying down my heartbeat was rapid.  The 2nd vaccine, it scared me and I almost went to the hospital but it stopped the next day.  The rapid heartbeat would come on suddenly.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  The subject had not been using contraception before becoming pregnant.  On 21 September 2011 the subject received booster dose of Boostrix (.5 ml, intramuscular, unknown site), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 05 March 2011 and estimated date of delivery was 10 December 2011.  Prenatal testing including ultrasound on 14 June 2011 and maternal serum alpha-fetoprotein on 22 July 2011 had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.       Lab Comments: Lab Tests: Ultrasound on 14 June 2011 and maternal serum alpha-fetoprotein on 22 July 2011 revealed no evidence of a defect.
Temp of 100.3 Pt's mother administered TYLENOL or ADVIL to control temp.
I got the shot on 8/23. Got a high fever that evening, chills, nauseous, body aches.  My chest started hurting, shortness of breath, chest heaviness also.  The other symptoms decreased after 24-48 hours but my lung issue continued.  I thought it would go away but it continued. When I would exercise, it felt like stabbing pains.  I had a race coming up and felt concerned so I went to Urgent Care on Sept 12th to get checked out. He verified I was not sick and nothing showed on my chest X-ray. On 9/18, I had my race and had horrible pains in my chest, stabbing pains in my upper back (which later found out was chest), and this worsened as the race continued.  After the race, I went to the ER as the pain was immense.  The ER doctor said this could be a reaction to the vaccine after doing  a CT scan and blood testing.  He said pleurisy but encouraged me to go to a pulmonologist if my symptoms continued once I got home.  I went home and my symptoms continued so I went to Doctor on 10/8/21. After him reviewing my symptoms, prior tests, history, he said I had I had mitosis and also called it diaphragm fatigue.  Said this was my body's reaction to the J&J vaccine. He said it would go away with time.  He lectured me on getting the J&J but when I asked if this could happen with other two vaccine, he said it could....
four friends that were in their early 50s that had mild strokes after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "four friends that were in their early 50s that had mild strokes after the vaccine".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours. He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend S had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old runner, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One day after the employee received the flu shot he awoke with a sore throat & lumps to his bottom inside lower lip & edge of his tongue. The lumps were sore/painful to touch & lasted x 1 wk. He did not seek medical treatment.
This spontaneous reprot was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 15-MAY-2015, the patient was vaccinated with a dose oral, ROTATEQ (lot # K015816) (expiration date, dose and route of administration were not provided). There was a 63 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Cerebral Stroke; Headache; Dizziness; Imbalance of her body; severe weakness; Vomiting; Nausea; Fever; Fatigue; Chills; Muscle pain; Joint pain; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebral Stroke) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (mild stroke) in 2017.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), HEADACHE (Headache) and VOMITING (Vomiting). On 13-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebral Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebral Stroke), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizziness), BALANCE DISORDER (Imbalance of her body), ASTHENIA (severe weakness), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.            On 10 Apr 2021 the Patient went to Emergency room and  her Computerized tomography (CT) scan done for stomach, results are not provided. On 13Apr 2021 the patient was again taken to ER and her Magnetic Resonance Imaging  (MRI) was done and diagnosed with Cerebral Stroke. The treatment medications include Acetaminophen , Promethazine, Apixaban  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The day after the vaccine around 8AM, I felt very bad with muscle pain and pain in my joints. My pain stayed and lingered until the dose 2, lot # 011AZ18. Later on that day, I felt more extreme pain in my muscles and joints. My pain was worse than before. It lingered but would come and go. Then I had dose 3 on 11/15/2021, I had elevated pain immediately in my muscles and joints. The pain continued and I went to the doctor. I was referred to a rheumatologist and they indicated that it could be polymyalgia rheumatica. I had blood tests and the lab work indicated that my numbers were off. I was put on prednisone and it helps ease the pain and inflammation.
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 27-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Allergy (Allergy to unspecified drug.).   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 16-May-2022. At the time of the report, COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient's symptom started on 09-May-2022 and 3 days after the patient started COVID-19 treatment. On 25-May-2022 at 12:00 the patient's symptoms came back after 8 days from the last dose taken.  It was unknown if patient received any treatment for recurrence of COVID-19. COMPANY COMMENT: This is an spontaneous case concerning a 38-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 194 days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 38-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 194 days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.
Chief Complaint  COVID+ yesterday. SOB, cough, and fever last noc requiring O2 so nursing home staff wanted pt evel'd further  History of Present Illness  The patient is a very pleasant 56yo F. LUE fistula, insulin-dependent diabetes mellitus type II, chronic pain on chronic opiates, GERD, and gout who was brought to the ED today for evaluation of dyspnea and cough. History is difficult as she is somewhat somnolent and dyspneic. She reports that she was feeling in her usual state of health until yesterday, when she noticed that her legs were weak, so she asked to be tested for COVID-19 and the test was positive. She then developed a cough and fever yesterday evening. Overnight, she became hypoxic and ultimately required oxygen supplementation, so staff brought her to the ED for evaluation. She has been vaccinated against COVID-19 and reports that she only goes to dialysis, so is not sure where she was exposed. She denies chest pain, nausea, vomiting, diarrhea, constipation, abdominal pain.   In the ED today, CXR shows bilateral pneumonia and she is requiring 4L O2. Troponin is mildly elevated at 0.11 which is stable compared to previous troponin results here; she denies chest pain and EKG shows LBBB similar to previous with no new ST-T changes. She received dexamethasone 6mg PO once. She has been a very difficult IV stick but eventually IV access was obtained.
had arm pain; muscle aches; fever; chills; Booster; had severe nausea; vomiting; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Dec2021 (Lot number: FD0809) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN, codeine. Concomitant medication(s) included: ELIQUIS. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: PCN, codeine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153), administration date: 08Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613), administration date: 18Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "had arm pain"; MYALGIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "fever"; CHILLS (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "chills"; NAUSEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "had severe nausea"; VOMITING (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "vomiting"; DIARRHOEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "diarrhea". Therapeutic measures were not taken as a result of pain in extremity, myalgia, pyrexia, chills, nausea, vomiting, diarrhoea.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
CoughWheeze, Tachycardia, hot flashes, scratchy throat Narrative:
COVID arm - histamine response at vaccination site. Itchy, swollen, painful. Severe for 2 days, mild for 3 additional days.
Patient answered the call in to the shot room and verifed her last name.  After she received the Pfizer dose she realized she was here for a RSV and Flu shot.  It was then realized that she was the wrong patient.  She said she received her pfizer dose 4 weeks ago.