chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she is calling regarding the booster; she is in bed and can't even move.; she has blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "she has blood clots"; IMMUNISATION (medically significant), outcome "unknown", described as "she is calling regarding the booster"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she is in bed and can't even move.". The patient underwent the following laboratory tests and procedures: chest x-ray: (2021) blood clots; echocardiogram: (2021) blood clots. Additional Context: She states that she had a horrible effect with the Pfizer booster shot, the vaccine. She states people are suffering because of taking this vaccine. Caller states that this does not sound hopeful and that maybe she will go on social media and tell people not to get the vaccine. This is not right. She states that Pfizer needs to at least, take responsibility. She was perfectly fine and this vaccine just wrecked her. She states that she is in bed and can't even move. She states that they all ready did a chest X-ray, an echocardiogram and they called her this morning and told her she has blood clots. It is not even just the heart. They are now saying they want to do a CAT scan of the lungs. Who is going to pay for all of this.  The lot number for bnt162b2 was not provided and will be requested during follow up.
My left arm was sore the day after vaccination but soreness went away quickly. 8 days after vaccination, a rash formed on my left bicep about the size of a quarter. Today, (Day 9 post vaccination), the rash is about the sized of a plum and is very hot to the touch.  I have not sough any medical treatment at this time. I read about Covid arm but am reporting these symptoms as the rash is on the same arm where i received the vaccination but not the same location.
The day after receiving the vaccine, the arm that I got the vaccine in was in severe pain. I would say 7/10 pain. Anything even slightly brushing against it was very painful. It was a little red and hot to the touch. I woke up multiple times through the night because of the pain. I did NOT take anything for it. By the following morning it was just sore, like how you normally would feel after a vaccine.
Patient was received vaccine at about 11:00 am, and was instructed to hangout for 15 minutes after for routine monitoring. He left before those 15 minutes were up. No history of allergy or anaphylaxis to previous vaccines, or any ingredients in the vaccines. ALERT shows both vaccines have been administered in the past, patient stated he has had no issues either with previous vaccines. Patient returned about 20 minutes later complaining of waves of severe lightheadedness, no other signs of allergic reactions or symptoms (example: difficulty breathing, nausea, swelling, etc.). Patient stated he may be dehydrated, gave him some water and had him sit down for a little bit to see if symptoms subside. About 5 minutes later patient said while drinking water he felt that his throat was feeling a little bit tighter but no difficulty breathing or facial swelling, or injection site swelling . We advised patient to go to urgent care across the street. Patient agreed, and pharmacist phoned urgent care to confirm patient had arrived, was admitted, and was getting care.
Hives on abdomen, hand swelling, itching on head, severe abdominal pain and sudden onset of diarrhea, general all over itching, took Benadryl and goes to sleep.  Awoke at 10 pm asymptomatic.
blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis; Associated fever; This spontaneous case was reported by a consumer and describes the occurrence of PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: J and J (Patient vaccinated with J and J first). Past adverse reactions to the above products included No adverse event with J and J.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) (seriousness criterion medically significant) and PYREXIA (Associated fever). At the time of the report, PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) was resolving and PYREXIA (Associated fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Patient got vaccinated with J and J first and after 4 months we were asked to have a one-shot MODERNA. Patient got diagnosed by pennicolitis. After ten days It got really better but patient suffered a lot.  Company Comment - This case concerns a patient of unknown age and gender with a history of Johnson& Johnson vaccination for COVID-19 who experienced the unexpected serious event of panniculitis. The event occurred on an unknown date after vaccination with mRNA-1273 vaccine on an unknown date. The rechallenge was unknown as information about the date of dosing was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with a history of Johnson& Johnson vaccination for COVID-19 who experienced the unexpected serious event of panniculitis. The event occurred on an unknown date after vaccination with mRNA-1273 vaccine on an unknown date. The rechallenge was unknown as information about the date of dosing was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
CONGESTION; COUGH; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to the Left Arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fatigue. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4. On 18-MAR-2021 05:30, the subject experienced congestion. On 18-MAR-2021 05:30, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of congestion, cough and fever was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning a 24 year old female with allergic reaction to CECLOR, KEFLEX and BACTRIM allergy and no pertinent medical history who on 26-JAN-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included TOPAMAX and NUVARING. On 27-JAN-2010 the patient experienced itchiness all over her body. Only when the patient scratched the area, it turned to "hives". There were no lad diagnostic studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Heart pain; nausea; vomiting; soreness around injection site; weakness overall; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Lot number: GJ2524) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Is bivalent: False, lot number: EW0173, dose number: 2), for Covid-19 Immunization; Bnt162b2 (Prev dose product: COVID 19, Is bivalent: False, lot number: EW0151, dose number: 1), for Covid-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "recovering", described as "Heart pain"; NAUSEA (non-serious), outcome "recovering"; VOMITING (non-serious), outcome "recovering"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "soreness around injection site"; ASTHENIA (non-serious), outcome "recovering", described as "weakness overall". Therapeutic measures were not taken as a result of angina pectoris, nausea, vomiting, vaccination site pain, asthenia.  Clinical course: The patient received other vaccine Regular Flu Shot (non allergy one) in four weeks. The patient did not have covid prior vaccination, was not covid tested post vaccination, Known allergies: None  No follow-up atempts are possible. No further information is expected.
Menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: QVAR; ATENOLOL; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; MUCINEX. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Primary Immunization completed), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 booster, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 17Sep2022 at 15:00, outcome "recovering", described as "Menstrual bleeding". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for adverse event. No known allergies are reported. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Administration data indicates your location administered doses of the affected lot after the Sept. 30 expiration date but on or before Oct. 19. For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required.
Information has been received from a health professional concerning a healthy 11 year old female with no known medical history who on 8/28/96 was vaccinated with a dose of varicella virus vaccine live (lot # 617355/0567D). On 10/31/04 the patient developed chicken pox with 15 lesions. It was reported that the patient was afebrile. Unspecified medical attention was sought and no treatment was prescribed. At the time of the report the patient was recovering. There was no product quality complaint involved. The reporter indicated that the patient's brother (WAES0412USA00533) developed chicken pox following exposure to varicella virus vaccine live (lot # 617355/0567D). Additional information has been requested.
Ten minutes after vaccination, patient experienced Chest pain, shortness of breath, dizziness, nausea and vomiting and dry mouth.   Since 4:30 AM patient did not eat anything except for crackers and half of a granola bar
She was + for covid 9-  16  -2021 at  Med Center.  She was admitted there apparently.  She was admitted 9-25-21 to Hospital  and discharged 11-18-21 and admitted to another hospital same date until  1-8-22  :    dx include  pneumonia due to covid, resp failure with hypoxia, acute kidney failure, cardiac arrest , copd, Hyperosmolality, anemia, hypertenisve heart disease, malnutrition,
stroke; trouble walking; Difficulty getting out of bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On 19-Feb-2021, the patient experienced MOVEMENT DISORDER (Difficulty getting out of bed). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident; Rehabilitation therapy for Movement disorder and Rehabilitation therapy for Gait disturbance. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), MOVEMENT DISORDER (Difficulty getting out of bed) and GAIT DISTURBANCE (trouble walking) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown unknown. In 2021, Magnetic resonance imaging: abnormal Abnormal.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  The patient got worse so was sent for MRI was done and showed something. The patient stated the stroke has affected his right side and has trouble walking. He was in the hospital for 3 days. He then went back for rehab hospital and there for about a week. He is now home and doing out patient rehab.  No concomitant medications were reported.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
administered expired dose of Daptacel, no AE reported; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a non-hcp (office staff).  This case involves 12-month old female patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number: c5180ba expiration 6-Apr-2019, via intramuscular route and in left thigh on an 10-Jun-2019.  The patient's medical history and family history were not reported.  Concomitant vaccination included a dose of pcv13 and hib vaccine.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
The day after the shot started coughing and short of breath which worsened until shortness of breath was severe enough to go the ER on 3/9/21 at which time admitted to the hospital with fluid overload and hypoxia. Stayed in the hospital until 3/12/21, discharged home on oxygen and still coughing intermittently. Additional symptom of extreme fatigue.
Feeling dizzy; blurred vision; vertigo; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if the vaccine contains polyethylene glycol and sulfur. She also mentioned that she had an immediate response to the first dose. The patient experienced feeling dizzy, blurred vision and vertigo on an unspecified date. The events lasted for about 4 hours but got better. The patient said she is hesitant in getting the second. Outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt reported chest pain (mid chest, mild pressure) few minutes post vaccination & suspects it is related to anxiety. Denies SOB/dizziness/difficulty breathing. AOx4; BP 124/68; HR 65. Pt reported improvement upon laying down & drinking water. Pressure pain improve, ambulated w/out difficulty. Instructed to call 911 if CP worsens or if difficulty breathing.  Pt will follow, released from vaccination site in stable condition
Information has been received from an 85 year old female consumer with pulmonary hypertension, a penicillin allergy and a codeine allergy who in October 2006, was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium, Lipitor, Coreg, Plavix, Accupril, Aspirin and hydrochlorothiazide. On 08 Dec 2006 the patient woke up from sleep because of intense pain in her right breast that rotated to the back onto the right arm to the elbow. It was reported that the pain would come and stab. The patients skin was sensitive to anything that would touch it. She went to the doctor and was diagnosed with neuralgia. On 18 Dec 2006 the patient noticed "raspberry marks" under her breast and on her back. She went back to the doctor and was diagnosed with shingles. There were 3 major rashes under the arm and others were scattered around the back. There was no product quality complaint involved. No additional information was available. 6/17/10 Additional information received from the physician indicated that on 22-SEP-2006, prior to vaccination the patient's VZ AS was 1.65 (>1.10). The patient was vaccinated SC in the left delotid with a dose of varicella-zoster virus vaccine live (Merck) on 04-OCT-2006. The patient began having symptoms on 11-DEC-2006, her zoster eruption began on 12-DEC-2006. The patient was diagnosed on 19-DEC-2006 with zoster at approximately TB on the right side. Additional labs were not performed. On an unspecified date the patient recovered. No additional information was available.
Very active & healthy prior to vaccine, no pre-existing conditions or medications.  9/10/21 vaccine date.  Have been to ER twice for severe chest pain (thought it was a heart attack) and doctor 3 times, they cannot figure out what is wrong, all tests show nothing.  No treatment appears available to me because doctors are not being instructed about what to do about/how to treat vaccine side effects.    Initially arm soreness & tired from vaccine.  Starting on 9/19 - nine days after receiving the J & J vaccine, developed daily left and center chest pain & pressure, headaches, fatigue, muscular weakness, dry cough, sleeplessness (never had any of these symptoms except maybe a mild headache just once a year).   Three times after 9/19 had shaking, sweating & shivering for hours in the middle of the night.  From 9/19 to 10/10 blood pressure was elevated to mid 140?s over mid 90?s (never had blood pressure issues before).  Since 10/10, BP appears to have returned to normal.  From 10/10 to this date of submission (10/22/21) all symptoms (other than elevated BP) continue and are mostly moderate but have ranged from mild, moderate and ER level severe.
8/21/21  PMH HTN, BPH who presents for BRBPR
This spontaneous report has been received from a registered nurse, concerning a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not provided. On 26-SEP-2018, the patient was vaccinated with PROQUAD therapy type rHA, route intramuscularly instead of subcutaneously, lot # R006751 with expiration date 03-SEP-2019 (dose and frequency were not provided) for prophylaxis. No adverse effect reported.
'Near-syncope' event after - few minutes after phlebotomy and then vaccines, and while watching younger sib get vaccines, the patient suddenly felt lightheaded, nauseous got pale, diaphoretic, then vomited. No LOC. Sat/rested and was fine within few minutes, discharged to home, VS remained stable.
15MAR PM-wooziness, pain in rt leg all the way to toes;16MAR AM OK-PM droggy, fever, intestinal cramps, myalgia, exhaustion;17MAR vomited 30 min, h/a, bloating, green nasal mucous, pasty coated mouth, joint pain, cant stand
Immunizations given on 11/19/2007. Mom states infant had "red bump" on L side of buttocks which spreaded to scrotum area and "high temp". Primary MD P O Treatment 11/21; ER 11/23;  MC admission 11/23/07;  Wound Culture per microbiology - "MRSA"; IV antibiotics given. Discharged 11/28/07 on Cleocin by mouth. Admit diagnosis: Cellulitis L Buttock and L Leg (not in same area of injection site);  D/C Summary improved with antibiotic treatment. 1/22/08-records received for DOS 11/23-11/28/07-DC DX: Left leg abscess and cellulitis status post incision and drainage. MRSA positive. 11/20/07-Swelling at injection site day after vaccination, small pimple. 11/22/07-red area left hip, temp 105. Refused to weight bear on left leg. Fluctuan area palpated and 10cc serosanguinous fluid aspirated from site with subsequent incision and drainage.