chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other severe and personal injuries which are permanent and lasting in nature/other related health complications; Guillain Barre-Syndrome; Information has been received from a lawyer regarding a case in litigation referring to an approximately 61-year-old female patient (pt). Information about concurrent condition, medical history and concomitant medication was not reported. On 24-AUG-2013 (conflicting information, also reported at 63 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2014, the was caused to suffer Guillain barre syndrome, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including Guillain barre syndrome, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, the pt required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The pt was informed and believed and further alleged that the pt would in the future be required to obtain further medical and/or hospital care, attention and services. As a foreseeable, direct, and proximate consequence of the pt's actions, omissions and misrepresentations, the pt suffered Guillain barre syndrome and other related health complications (ill-defined disorder). The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the events was not recovered.  Upon internal review, Guillain barre syndrome was determined to be medically significant. The events Guillain barre syndrome and ill-defined disorder were considered to be disabling by the lawyer.
Patient is a 57 y.o. Caucasian male involved in an approximately 6-foot fall from a his semi truck earlier this afternoon. He did hit his head which caused him to strike his head. Per report, brief LOC. Evaluated and found to have SDH and clavicle fracture. Patient was also in Afib with RVR, patient was given 20 mg of Cardizem. Patient was given 4 mg of zofran prior to arrival, upon arrival in the ED patient vomited. No known medical conditions. No known drug allergies
CHILLS; HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 4:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:32 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20.01 for dose administered on 27-APR-2021 . No concomitant medications were reported. On 19-APR-2021 , the vaccine with batch number 007C21A was moved to fridge. On 27-Apr-2021, 8 vials were moved to the clinic. On 27-Apr-2021 at 9 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 10:45 (Lot number: 330368D) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe allergic reactions to synthetic preservatives" (unspecified if ongoing); "allergy to dyes, colors" (unspecified if ongoing); "allergy to fragrances" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to zithithromycin" (unspecified if ongoing); "Allergy to doxycyclin" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing); "Allergy to anaprox" (unspecified if ongoing); "Allergy to antibiotics with sofa" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe hives"; DIARRHOEA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe diarrhea"; RASH (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "rash"; ERYTHEMA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "red burning skin from scalp to knees covering entire body"; LYMPHADENITIS (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "inflamed lymph nodes in scalp neck underarms chest"; PRURITUS (non-serious), THROAT IRRITATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "itchy ears, throat"; EYELID MARGIN CRUSTING (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "crusty eyes/eyelids"; ARTHRALGIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "joint and back pain"; BACK PAIN (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "back pain". Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain.Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain and included treatment with diphenhydramine hydrochloride (BENADRYL) and steroids (STEROID). Prior to vaccination, the patient was diagnosed as 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.
This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis. The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees Centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is a non-valid case due to lack of patient identifier. Follow up information was received on 26-SEP-2018. On 26-SEP-2018, a call was placed to the primary reporter. A receptionist answered the call and shared that the reporter no longer worked there. She transferred call to an other (unspecified reporter) and a request was made for patient identifiers and vaccination dates. Follow-up information was received was received from a non-healthcare professional concerning a 5 year old patient of unknown age. On 20-JUL-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 for prophylaxis. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.
Felt a bit dizzy; Slept a lot that same day of the vaccine; Felt a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired). At the time of the report, DIZZINESS (Felt a bit dizzy), SOMNOLENCE (Slept a lot that same day of the vaccine) and FATIGUE (Felt a bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-142902 (Patient Link).
p/vax pt had fever of 105 & mom gave child APAP & a cool bath;child taken to PCP & told rxn to vax;mom instructed by PCP to alternate APAP & advil;next day mom reported child seems to be OK-fever broke;
3 days after first dose - headache, dry mouth, loss of taste, fatigue, stomach pains, bloating, belching, reflux, diarrhea, brain fog, no appetite. Saw healthcare provider. Given restricted diet, ordered abdominal ultrasound. Symptoms lasted 13 days. 2 days after second dose - same symptoms, but more intense/extreme. Healthcare provider has ordered abdominal MRI. Still experiencing symptoms.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-FEB-2011 the patient the first dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported), second dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported) on 25-MAY-2011, and was receiving a third dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported) on 18-JUN-2013. No adverse effects were reported. Additional information has been requested.
5:58pm received fluzone, IM, L deltoid  6:10pm became flushed and began to feel tightness in throat - pt self administered one puff of albuterol inhaler.   6:12pm pt c/o stomach cramps and ongoing throat tightness, she self anministered epi-pen L thigh. BP 200/100 pulse=100 6:38 pt feeling "a little better",and did not want ambulance called,but then stomach cramps started again, 911 was called. 6:45 2nd dose of IM epinepherine given as pt cramps getting worse (her typical symptom with anaphylaxis)sx subsiding by the time ambulance crew arrived at 7:00pm-pt transported to hospital.
TEMPERATURE EXCURSION. vaccine was stored in freezer longer than manufacture recommendations. Patient did not have any adverse reaction.
Lips, throat, tongue numb.  BP up to an unstable level 167/95.  My normal press is 118/64 before March 25.  I now have a killer headache sine the 25th my face by the TM aches.  I can't get rid of it
Chills, Generalized Aching, Shaky, Fatigue, Arm sore from Elbow to top of Shoulder, Headache.
This was the Phitzer - second dose on 06/06/2021. On July 27th i developed Bells Palsey. I have not been sick or had any virus. I have not have COVID at all. I was unaware the vaccine could cause this. Very miserable. Affecting my job and life.
Next day extreme fatigue and muscle pain. Also extreme bone pain in shins , arms and back. Almost like going through a growth spurt. High fever. Nausea. Redness and swelling at injection site which has lasted over 48 hours. Headache and muscle pain.
Rash on arm at injection site, appearing 1-1/2 weeks after first injection. (Covid Arm)
Two days after getting the shot I noticed my right arm/hand were swollen with a tingling sensation. There is also a lump at the injection site that is warm to touch and itchy.
ROTAVIRUS IMMUNIZATION WAS GIVEN INTRAMUSCULAR BY STAFF AND SHOULD HAVE BEEN GIVEN ORALLY. PATIENT WAS BROUGHT BACK TO CLINIC AND GIVEN DOSE ORALLY AS WELL AS INJECTION SITE OBSERVED BY M.D. NO ADVERSE REACTION WAS SEEN. PATIENT RETURNED TO CLINIC AFTER 7 DAYS FOR INSPECTION OF INJECTION SITE. NO ADVERSE REACTION NOTED.
1/14/22 pt found to be positive for COVID after 1 wk of increasing SOB and cough; Chest x-ray showed bilateral pneumonia; A Fib with RVR; on Vapotherm and steroids; dc'd to rehab facility (Health and Rehab for myopathy/polyneuropathy related to COVID respiratory failure; will need to improve overall functioning to return to home; OT and PT in facility; pt to continue O2 supplementation, albuterol inhaler, Breo Ellipta, Mucinex; found pt unresponsive and with a thready pulse in facility; code blue called; ROSC never achieved; pt expired in the facility
Over the next week the spots that itch; Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face) and RASH PRURITIC (Over the next week the spots that itch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face). On an unknown date, the patient experienced RASH PRURITIC (Over the next week the spots that itch). At the time of the report, RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face) and RASH PRURITIC (Over the next week the spots that itch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information provided included, seen a few doctors over Telehealth and was given a prescription for prednisolone which she completed with no change.
On the one-week date after shot, injection site on left arm started to feel hard. As day progressed, continued to harden, swell, and get very itchy
Fri, 9/24 - Vaccine injection #2 (no symptoms) Sat, 9/25 - Headache, fatigue/exhaustion, dizzy, sore/achy joints, nausea & swollen glands (in my throat) Sun, 9/26 - Headache, fatigue/exhaustion, dizzy, sore/achy joints, burning throat (felt like it was on fire) Mon, 9/27 - Headache, fatigue/exhaustion, dizzy w/exertion, dry cough + wheezing + SOB/short-of-breath (all with exertion) Tues, 9/28 - Headache, fatigue, dry cough with dizziness, wheezing and SOB (had to call off/miss work) Wed, 9/29 - Headache, dry cough with dizziness, wheezing & SOB & inhaler use (had to call off/miss work & get Covid test) Thurs, 9/30 - Headache, dry cough with dizziness, wheezing & SOB & inhaler use (Covid Test resulted negative) Fri, 10/1 - Headache, dry cough with dizziness, wheezing & SOB & inhaler use (attempted to go to work, wheezing and SOB worse & used inhaler multiple times to get through shift) Sat, 10/2 - Headache, dry cough with dizziness, wheezing & SOB Sun, 10/3 - Dry cough with dizziness, wheezing & SOB Mon, 10/4 - Dry cough with dizziness, less wheezing, SOB
PUI went to the ED with shortness of breath and suspected covid pneumonia on 4/6/21. Tested positive for covid on 4/7. He was discharged on 4/13. Main diagnosis was hypertensive heart disease with heart failure (acute left systolic heart failure). Other diagnoses included acute systolic congestive heart failure, hypo-osmolar hyponatremia (low blood sodium), hemoptysis, type 2 diabetes without complication (on insulin long term), pneumonia, coughing up blood (hemoptysis), HIV infection, hypertension, hyperlipidemia, hypokalemia, mitral and tricuspid valve disorders (regurgitation). He also has a history of tuberculosis.
Severe soreness throughout entire right arm, so strong that I was unable to use it for a full 24 hours.  Followed by itching, bad itching at injection site and left shoulder that lasted around 36 hours.
inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. 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. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
1st dose - reaction of arm swelling, pain, redness 2nd dose - facial pain, dry mouth, headache, nausea, lethargy. left-sided face pain following the widespread face pain, the face pain occurred a second time two months later and can best be described as Left-sided and similar to what is described as trigeminal nerve pain
I am infertile/no period , I have not been able to find help for this. Months after I have gotten sick more times than before. I have not contracted COVID one time during the pandemic I always stayed cautious I got the vaccine because of work and have been more sick than ever before that I?ve had family notice .
client with mitral valve prolapse diagnosis since age 13 or 14yo. Reports has not had chest pain or shortness of breath X 4yrs.  Reports began experiencing intermittent periods of chest pain with SOB since seven days following vaccination.  She was seen in the ER on 3/31/03, was not having symptoms at that time and was cleared for discharge.
Awoke with numerous hives - 06/21/2005.  Taken to emergency room by parents, 06/21/2005.  Returned to clinic 06/22/2005 - given Benadryl for Urticaria and instructions for return if needed.
17 year-old patient received FLUBLOK QIV vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse (Reference number- 00817095) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 17-year-old male patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2108 and expiry date 30-May-2022) via intramuscular route in the left deltoid on 25-Sep-2021 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of report, no adverse event 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 the Directive. 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.