chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 18MAR97 & 19MAR97 pt exp severe h/a, neck stiffness & sore lymph glands;
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 14-JUL-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered herpes zoster in his right axillary region with burning sensation and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event herpes zoster to be disability.
I had pains in my stomach loss of appetite. I made an appointment to see my doctor to find out what was going on. I had to CAT scans and an ultrasound. It was found that I had ulcers in my colon, I had drain tubes put in for ten weeks before they could surgery. I then had surgery where I was cut from below my breast to my pelvic bone. They had to remove part of my colon, small intestines, an ovary, a temporary ileostomy was put in that should be removed in June. I am still having some issues with my blood pressure, keeping food in my body, fatigue.
LEFT CALF TO ACHILLES SORENESS; FLU SYMPTOMS/ BODY ACHES/ LETHARGY/ DECREASE APPETITE/ CHILLS/ FEVER; LEFT CALF TO ACHILLES SORENESS; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included difficult breathing, and concurrent conditions included asthma, non-smoker, non-alcohol use, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced left calf to achilles soreness. On 12-APR-2021, the subject experienced flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever. On 12-APR-2021, the subject experienced left calf to achilles soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever on 14-APR-2021, and had not recovered from left calf to achilles soreness, and left calf to achilles soreness. This report was non-serious.
RINGING IN HEAD; RINGING IN EARS; VERTIGO; DIZZINESS; This spontaneous report received from a consumer concerned multiple patients 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced ringing in head, ringing in ears, vertigo, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in head, ringing in ears, vertigo and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210407556.
Information was received from a consumer on 30-OCT-2015 via Sanofi Pasteur (MSD) and refers to an unspecified number (reports as hundreds) of children patients of unknown ages and genders. This report was found in the comments part of a petition about HPV vaccine. On an unspecified date, the patients were vaccinated with GARDASIL (lot number, expiration date, dose and route of administratoin were not reported). There was no concomitant medication reported. The reporter stated that "its hard to imagine that GARDASIL an other vaccines for the HPV virus were stll on the market knowing the hundreds of our children that had died (1511USA002460) and those that had harmful adverse reactions (not specified) and were living with new medical conditions after receiving the vaccine (not specified)". This is one of several reports from the same reporter. Additional information u
sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN0207) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "systemic lupus erythematosus nephritis", start date: 1980 (unspecified if ongoing), notes: she had SLE which is systemic lupus erythematosus nephritis with kidney involvement.; "stage three renal failure" (unspecified if ongoing); "hand surgery" (unspecified if ongoing), notes: Given oxycodone and tylenol. There were no concomitant medications. Past drug history included: Oxycodone, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up; Tylenol, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up. Vaccination history included: BNT162b2 (DOSE 1, SINGLE: Lot number: EN6198,), administration date: 19Feb2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "sick", "COVID-19", "Drug ineffective". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.
12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE.  12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM.  I TOOK SOME IBUPROFREN, TYLENOL.  12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD.  COVID TEST; NEGATIVE
Pt reported muscle pain & numbness- can't lift arm all the way, persisting several days after injection- at least 5, not responsive to NAPROXEN. No swelling, itching or rash. Advised to seek medical attention.
could feel the vaccination site on the left arm; Itching left arm vaccination site after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose). At the time of the report, VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.           Patient reported that the feeling goes away and comes back.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-573734, MOD-2022-573732 (Patient Link).
Information has been received from a certified medical assistant concerning a patient who was vaccinated (date unspecified) with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), and developed a local site reaction. The patient had an allergy to neomycin. The CMA noted that the individual is not their patient, but a family member of one of their patients. No further information is available. There was no product quality complaint. Additional information is not expected.
Headache, Fever, NauseaVomiting, fatigue,chills, injection site red and itch
vomiting; weak; This is a spontaneous report received from a contactable consumer (the patient). A 36-year-old female patient received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine this past Wednesday (unspecified date). She has been weak and vomiting. She has not been able to get anything done. She would like to know if this as an excuse to miss work, and how long will side effects last. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-FEB-2015, the patient was inadvertently vaccinated with an improperly stored single dose of ZOSTAVAX, subcutaneous (dose and lot number were not reported). No adverse effects were reported. Additional information is not expected because the reporter did not wish to be contacted.
pt had a positive COVID test on 9/3/21 at Clinic; 9/5/21 EMS called to pt's house for unresponsiveness; found to not have a pulse; CPR started and cardioverted with ROSC achieved; intubated in the field; brought to ED; signs of anoxic brain injury with seizure-like activity; family stated pt did not want to be intubated; pt passed away in the hospital
A healthcare professional reported that a 66 year old male received an injection of Pnu-Imune 23 on 01/22/01. The same day, the patient  developed an injection site reaction characterized by swelling, redness, and warmth which extended to his hand. The patient was treated with applications of warm compresses, which reportedly did not relieve his symptoms. On 01/25/01, he was prescribed Medrol Dosepak. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 469-132.
The patient received second dose of the Moderna vaccine on 04/19/2021.  The dose was administered 21 days after the  first dose was administered on 03/29/2021.    The patient is being monitored for any adverse reactions.  As of 04/24/2021, the patent denies any symptoms.
50 hours after shot, debilitating classic migraine for 3 hours.  Relieved with 7.5 mg hydrocodone pill.  74 hours after shot, 2nd debilitating classic migrane for 5 hours.  Relieved with 7.5 mg hydrocodone pill.  Nausa for 3 hours after migraine.  Vomiting 45 min after eating part of sandwich at 80 hours after shot.  98 hours after shot, ocular migraine for 45 min, then general headache in back of head for 1 hour.
became ill on 9/24/21 with fever, body aches, congestion, heaviness in chest, several immediate family members within household positive for COVID around same time frame
Pt recvd 2 doses of Engerix-B & 20JUL92 following dose 2 exp general malaise & fever;
VARICELLA GIVEN ON 9/1/21 AND B.U.D WAS 8/31/21.
Within 4 hrs. of vax, pt had fever of 103; mom gave APAP & pedialyte and continued to give meds over weekend; pt cont to run fever; mom took pt to ER in AM OF 13APR92 where OM was dx'ed & amoxycillin was started;
hives become large & happen @ different site on body;this has been for 2 1/2months;
Could barely walk; Could barely talk; Blood sugar dropped significantly; Dizzy/ Lightheaded; Unable to swallow; Weak; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Blood sugar dropped significantly), DIZZINESS (Dizzy/ Lightheaded), DYSPHAGIA (Unable to swallow), ASTHENIA (Weak) and DYSPNOEA (shortness of breath) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Nasal swab test) on 12-Aug-2020. Concurrent medical conditions included Hypertension, Anxiety and Drug allergy (Allergic to Codeine - Resulted in Vomiting). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMLODIPINE for an unknown indication.   On 26-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced BLOOD GLUCOSE DECREASED (Blood sugar dropped significantly), DYSPHAGIA (Unable to swallow) and DYSPNOEA (shortness of breath). 23-Apr-2021, the patient experienced DIZZINESS (Dizzy/ Lightheaded) and ASTHENIA (Weak). On 28-Apr-2021, the patient experienced GAIT DISTURBANCE (Could barely walk) and SPEECH DISORDER (Could barely talk). At the time of the report, BLOOD GLUCOSE DECREASED (Blood sugar dropped significantly), DIZZINESS (Dizzy/ Lightheaded), DYSPHAGIA (Unable to swallow), ASTHENIA (Weak), DYSPNOEA (shortness of breath), GAIT DISTURBANCE (Could barely walk) and SPEECH DISORDER (Could barely talk) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2020, Viral test: positive (Positive) Positive. On 28-Apr-2021, Blood glucose: 73 (Low) 73. On 28-Apr-2021, Blood test: normal (normal) normal.         Patient had undergone EEG, MRI scanning and was waiting for results. Treatment medicines were not inlcuded   This case was linked to MOD-2021-101864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow Up received on 02-JUL-2021, patient demographics, concurrent medical condition, lab data, first dose information and new events updated. On 19-Jul-2021: Non significant follow up received on 19-JUL-2021.
Initial unsolicited report received from a pharmacist on 14 November 2016. This case involves an elderly female patient (age at onset not reported) who was vaccinated with Fluzone HD intramuscularly (batch number: UI731AA, expiry date: 09 June 2017; dose and dose in series were not reported) in the left arm and Pneumovax (batch number, expiry date, dose and dose in series, route and site of administration were not reported) in the right arm on 04 November 2016. As per the reporter the patient did not have any allergies and was not ill at the time of vaccination. No further information was reported regarding patient's medical history. Concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient could not move her right arm. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time.
pt devel redness, swelling & itching @ inject site, coincident w/flu vax; react lasted about 1 month; f/u pt noted that also exp visual disturbance & fever sore;
She had a rash down her arm, pain (couldn't sleep on that arm for a week) and swelling.
Patient is past the 42 days after first Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past the 42 days after first Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past the 42 days after first Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past the 42 days after first Moderna vaccine) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient failed to receive a second appointment for vaccination. No treatment information was provided.  This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, with no associated AEs.
Painful arm until Sunday, then throat felt tight, thought it was acid reflux so I took some tums. The heart palpitations started shortly after. Worse when lying down and almost felt short of breath. The heart palpitations continued until Monday night and Tuesday I woke up and palpitations resolved. I have only ever had this reaction one other time when had the Mirena. Symptoms resolved after having it removed but wasn?t sure what ingredients caused it. Now I believe there may be a common ingredient.
PFIZER BIONTECH WAS GIVEN BUT SHOULD OF BEEN THE PFIZER-BIONTECH BIVALENT VACCINE. NO ADVERSE EVENTS REPORTED
Patient had received first Pfizer vaccine dose on 8/3/2021.  Contracted and was hospitalized with COVID-19 on 8/17/2021 prior to receiving a second dose of the vaccine.  Patient was ultimately intubated during hospitalization. Patient eventually extubated and has since been recently discharged from inpatient rehab to home on 9/25/2021.
received improperly stored vaccine; No additional AEs were reported; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 18-MAR-2022, the patient was vaccinated with one dose of the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) route of administration defaulted to oral, lot#U026664, confirmed to be valid with expiration date: 24-FEB-2023 or lot#1741817, confirmed to be valid with expiration date: 30-JUL-2022 (the reporter did not know which specific lot# was administered to the patient) and Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 1 dose, lot# U026217, confirmed to be valid with expiration date: 02-NOV-2023 (dose number, route of administration, and anatomical location were not provided), both for prophylaxis. The vaccines underwent a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
(Privacy), DO Physician Emergency Medicine ED Provider Notes     Addendum Date of Service:  04/08/22 1734 Creation Time:  04/09/22 0106     Expand All Collapse All     Hide copied text  Hover for details     Chief Complaint Patient presents with ? Shortness of Breath     per EMS, pt usually wears 1-2L o2 was found to be 84% this morning. Per facility pt more lethargic than usual. Pt 96% on 3L on arrival     HPI  87-year-old male with history of CHF, COPD, on 2 L chronic home O2, CKD, brought in by EMS from care facility for evaluation of generalized weakness and shortness of breath.  Caregivers found patient to be hypoxic, patient had to increase his home O2 to 4 L to maintain SPO2.  Patient denies chest pain abdominal pain nausea or vomiting.  Patient endorses generalized weakness.  Patient states he first started feeling ill yesterday.  No known sick contacts.  Review of Systems  CONSTITUTIONAL: +generalized weakness. +fevers +chills.  EYES: No pain or redness.  ENT: No sore throat or congestion.  CARDIOVASCULAR: No chest pain or palpitations RESPIRATORY: +cough. +shortness of breath. Denies wheezes.  GASTROINTESTINAL: No nausea, vomiting, or diarrhea.  GENITOURINARY: No dysuria or frequency.  MUSCULOSKELETAL: No acute pain or deformities SKIN: No rashes.   NEUROLOGIC: No headache, weakness, paresthesias, or LOC.  PSYCHIATRIC: No depression or anxiety
No issues immediately following vaccine.  About 11am, mild symptoms like 99.4 degree fever, muscle aches, joint pain, very mild nausea, fatigue began.  Severe nausea began about 7:15pm.  At 7:45pm, severe dizziness resulting in loss of consciousness and fall.  Seizure Syncope event lasted 2 1/2 to 4minutes.  Slow to wake.  Trembling/shaking in extremities, cold sweat.  Delayed speech.  Paramedics were called.  Went to ER at approximately 8:30pm.
ADACEL - 8-9-10. Arm swollen, red, painful 8-12-10. Felt warm all over, but no documented fever. Arm very red, swollen, warm. Rx: doxycycline.
Large Amount Swelling & Redness on Left Arm at Immunization site-9/12/20, About 800pm,  Earlier in the day, complaints of Left shoulder itching. Advised cool compress, Antihistamine, Tylenol
36 days since the first dose; Flu-like symptoms; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (36 days since the first dose), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included THYROID for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX) and ATENOLOL for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (36 days since the first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (36 days since the first dose) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100.0 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.