chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Zoster conjunctivitis; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 02-APR-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles (dose, route, and lot number not provided). Subsequently, the patient was treated by a healthcare provider for zoster conjunctivitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown.  Causality assessment was related.  Upon internal review, the event was considered as medically significant.
Provider hospital summary "Patient is a 74-year-old male with a past medical history of hypertension, asthma who presented with a extensive left lower extremity DVT.  Interventional radiology performed thrombectomy and angioplasty on 11/24.  Unable to place a stent at this time as they did not have the correct size of 16 mm.  Patient will need to remain on anticoagulation and follow-up with Interventional Radiology as an outpatient have stent placed.   this was emphasized with patient and contact information for Dr. was placed on AVS.  Patient is to remain on Eliquis strictly until stent can be placed and this was also emphasized to patient.  Some concern for May Thurner syndrome.  Transition from heparin drip to Eliquis on 11/24.  Pharmacy was contacted and did not have supply of Eliquis until 11/26 around noon.  Patient was discharged with 2 doses of Eliquis to get him through until that time.   Patient had some melena/weight loss/failure to thrive and GI was consulted.  He will need follow-up colonoscopy for screening purposes as an outpatient, deferred as patient was COVID positive.  His blood clot could have been caused by COVID certainly, but worried there may be possible malignancy.  His CA 19-9 was elevated and will need further evaluation and workup.  He will also need age-appropriate cancer screening.   Patient was incidentally found to have COVID and receive regenerate and therapy in the hospital."
Pt started experiencing rash/hive type symptoms on his arms + legs.  This started on 4/25/09 and was still present on 5/1/09.  Pt was advised to take Pepcid w/ Zyrtec or benadryl to relieve symptoms.
at 8000 hertz my right ear is 20db worse than my left ear; developed tinnitus in my ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Jan2021 (Lot number: EL9263) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroiditis", start date: 01Jan1990 (ongoing); "Glaucoma", start date: 01Jun2019 (ongoing), notes: Patient Details: Surgery both eyes 2019; "Lymphedema", start date: 01Jan1983 (ongoing); "Mycobacterium Avium Intracellulare", start date: 17Dec2019 (unspecified if ongoing); "Depression" (ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB] taken for depression, start date: Jan2000 (ongoing); SYNTHROID taken for autoimmune thyroiditis, start date: Jan1990 (ongoing); LUMIGAN taken for glaucoma, start date: Aug2020. The following information was reported: TINNITUS (non-serious) with onset 22Jan2021, outcome "not recovered", described as "developed tinnitus in my ear"; CONDITION AGGRAVATED (non-serious) with onset 25Aug2021, outcome "unknown", described as "at 8000 hertz my right ear is 20db worse than my left ear". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information- It was reported that patient received  her first covid vaccine on 20Jan2021. She noticed tinnitus in her right ear on 22Jan2021. Her hearing test of 25Aug2021 showed some loss in the (at 8000 hertz my right ear is 20db worse than my left ear). No follow-up attempts are possible. No further information is expected.
Parent report shortly after leaving the physicians office, patient had a seizure in the car.  Patient has a history of seizure disorder.  Patient was taken to the emergency room for evaluation and was discharge later that same day in stable condition.
Sore arm; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. As per the patient's knowledge, she had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient experienced sore arm and body aches. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and body aches was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
headache; Tiredness; some muscle aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches). At the time of the report, HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Gave 0.2mls of 5-12yo Covid vaccine, but was given undiluted. Will advise per CDC guidelines not to receive 2nd dose. Reaction unknown at this time.
Client walking in lobby post vaccination and leans toward the wall with arm while turning pale and falls hitting left side of head reported by witness. Client passed out. Upon awakening client reports., "Feeling dizzy and going toward chair remembered falling". Client reports that she does not remember hitting the floor or head. Area on left side of head with a feeling of soreness when questioned by nurse. Client observed in laying position on lobby floor. Client mother in lobby at time of fall declines EMS. VS  within normal limits for client taken by RN and observation provided with cool compress to neck and head. Mother (post vaccination incident) reports of two times of passing out that are non vaccine related.  7/22/19 client vaccinated at 16:45, fell in lobby at 1656 and recovered and left building at 1720 escorted by mother.  Follow up call to client at 1015  on 7/23/19 reports small bump on left side of head and no other symptoms after leaving clinic. & no evidence of bump today. Client rested at home the  evening and returned to work the next day (7/23/19).
Vaccine on 8/13/09 rash on lower torso 8/20/09 - Pain. Saw Dr. on 8/21/09 received Acyclovir and PERCOCET. Missed vacation - Better now 9-10-09.
Periods of apnea lasting approx 30 seconds in duration over a period of 30 minutes; apnea periods began @ home & continued while enroute to hosp; grandmother performed rescue breathing while enroute to hosp; pt adm to hosp;
Mom noted upon giving child a bath that he has a large red wheal around the site where I injected his MMRV one week ago.  Wheal bright red and measures 45mm X 35mm.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/25/2021 MUCUS PLUGGING, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/25/2021 BILAT PLEURAL EFFUSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/25/2021 BLEEDING
Pt is a 64yo F with no known PMH who presented today with Left side facial droop with left side neglect. She reports that around 1230, she felt like her knees became weak and she fell to the ground. She notes that the landlord found her and called EMS. Pt reports that she did not feel any other symptoms such as N/v, CP, dizziness, lightheaded, slurred speech, abd pain, visual changes, seizure like activity, incontinence, sore tongue, or SOB. It was noted by EMS that she had left side facial droop. Pt reports that she felt normal prior to this event and was able to do all ADLs and ambulate without assistance. She does not report any medical hx but admits to not seeing a PCP in years. She denies smoking and excessive etoh use as well as illicit drug use. She notes that she has a family hx of MIs with her brothers and sister all in the ages of 60. Her father had diabetes and HTN for which he passed from "GI blockage" and her mother passed from hemorrhage giving birth. She does not recall a family hx of stroke or abnormal bleeds.  In the ED, her vitals were significant for a BP 231/114. She had an NIH of 12 and a HCT was ordered showing right basal ganglia hemorrhage concerning for HTN cause. NSY has been called with patient started on cardene gtt and keppra. CBC significant for hgb 12.6 and CMP with K low at 3.1. EKG was obtained showing LVH with potential ischemia. Cardiology was called and noted that changes where likely in relation to LVH. A troponin was obtained and negative. Lastly, she has had a Head and neck CTA without evidence of Carotid artery blockage but an occlusion present at the distal P2 right PCA.
Per father patient has a history of "passing out" following vaccine administration and blood draws. Following this vaccination administration patient c/o of being lightheaded and displayed a brief moment of generalized syncope while seated in chair and diaphoresis noted. No trauma no fall. Vital signs taken and patient assessed by staff. HR 52, BP 98/76 . Patient a&o x4 conversing with staff. Patient able to eat and drink.
Mother noticed inward deviation of right eye on 11/1/06, immunization given 10/25/06. Patient had progressive vision loss starting 11/12/06. MRI shows multiple demyelinating lesions and bilateral optic neuritis, most likely diagnosis at this time is Acute Demyelinating Encephalomyelitis (ADEM). Further workup pending.  1/2/07 Received medical records from hospital which reveal patient admitted 11/13/06-11/17/06. HPI: 2-3 day hx of acute & worsening visual loss preceded by a 2 week hx of right eye deviation.  Initial s/s began w/preceding viral illness characterized by fatigue & low grade fevers.  Improved & given a flu shot.  Parent noted right eye medial deviation & was referred to ophthal but condition worsened prior to appointment & was admitted to hospital.  Began stumbling, could not feed herself & unable to complete play/puzzle tasks she had done previously.  Opthal exam in ER noted significant bilateral visual loss & inflammation of bilateral optic nerves.  Exam also revealed shotty cervical lymphadenopathy.  Treated w/high dose IV steroids.  Neuro, ophthal & neuro-opthal consults done.  Continued on tapering steroids on d/c to home.  Was to be followed by neuro, opthal clinics.  Although her vision improved in left eye to 20/160, right eye remained unchanged & was responsive only to hand movement with afferent pupillary defect & decreased right abduction.  It was not known if vision would be permanently impaired & family was referred to early intervention specialists.  FINAL DX: Acute Demyelinating encephalomyelitis.
Pt loss muscle control in legs, legs went weak and fell onto bed. Wife reports they had had CT scans to rule out TIA and are waiting on results from muscle and nerve tests.
6cm x 10cm anular erythematous indurated and warm reactions spreading x 4 days.
Pt's mother called office because after about an hour after receiving vaccines, pt broke out in hives.  Pt was brought back into office, given BENADRYL 4ml PO and DECADRON 7mg IM.  Pt was monitored for over one hour and released after hives subsided.  Allergy panels were ordered and we are awaiting results.
chest pains started later that evening,along with difficulty breathing,fever of 102.6,body aches and chills, joint pain,head ache,sore arm at injection site,fatigue,nausea.
severe respiratory congestion, tightness of chest, fatigue, body aches, fever lasting up to 9 days at this point.
patient accidentally received 2 doses of Boostrix 1 month; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient accidentally received 2 doses of Boostrix 1 month). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter reported that a patient accidentally received 2 doses of Boostrix 1 month apart and wished to know if there was any information available.  They asked to not have their information registered, did not provide specific information about the vaccines or event, only about the patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter reported that a patient accidentally received 2 doses of Boostrix 1 month apart, which led to extra dose administered.
Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I'm experiencing remind me of those: bloody sto, diarrhea, nausea, bloating, stomach cramping. The symptoms started about 30 minutes after the vaccine was administered. It took me this long to figure out it may have been the vaccine.   (The above is my main concern. I did also experience a stiff and painful arm which limited my range of motion, and fever.  But I expected those reactions. )
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the Pfizer product on 03/03/2020, 03/24/2021, and 10/20/2021. It is not specifically known if this person experienced symptoms of COVID-19 disease, but they tested positive on 12/06/2021 and 12/08/2021. They were admitted to hospital on 12/12/2021 and remained hospitalized until their death on 12/19/2021.
Multiple lumps - deltoid strength decreased 50% with (not inj site) - lower strength fastening clothing in back; - adjusting seatbelt.
Systemic: patinet felt cold-Mild, Additional Details: 10 Years old started feeling cool, father asked for Benedryl, patinet was given water. they stayed in obervation area for 30 mins
head feeling very hot, no fever.  occassional cough, and pain in right lung/chest.
patient received 2 doses of IPV at the same time; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number NL35L, expiry date 04-APR-2025) for prophylaxis.   Co-suspect products included POLIO VACCINE (IPOL) for prophylaxis.   Previously administered products included IPOL (1st dose received on an unknown date) and IPOL (2nd dose received on an unknown date). Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX), HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAXHIB) and HEPATITIS B VACCINE.   On 10-JUL-2023, the patient received Pediarix and IPOL. On 10-JUL-2023, an unknown time after receiving Pediarix and an unknown time after receiving INFANRIX, the patient experienced accidental overdose (Verbatim: patient received 2 doses of IPV at the same time). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUL-2023 The health care professional (HCP) called in to report the administration by mistake of Pediarix to a patient who received the same day Ipol, Infanrix, and PedvaxHib. The reporter mentioned that with Pediarix the patient received the 4th dose of HepB.  The patient received the 5th Dtap (Infanrix) and because of the maladministration of Pediarix, the patient received 2 doses of IPV at the same time. The HCP asked for potential adverse reaction following vaccination. During the call, permission to follow up was not requested. The patient received by mistake Pediarix and Ipol on the same day, which led to accidental overdose.
I was vaccinated,still got shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she vaccinated with Shingles shot and still got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Feet and toes were swollen; Throbbing pain; Chills that was scary; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 mg and NAPROXEN at a dose of 500 mg. At the time of the report, PERIPHERAL SWELLING (Feet and toes were swollen), PAIN (Throbbing pain) and CHILLS (Chills that was scary) outcome was 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.   Patient took Keflex 500 mg four times a day for 10 days. Naproxen 500 mg twice a day for 5 days. Patient took Naproxen for 4 days , then stop the treatment because patient couldn't sleep and it seemed like it wasn't helping with swelling. Patient has one more day left for her Keflex. Concomitant medications were not reported.
Arm pain described as sharp/nerve related  worst around day 4 after vaccination. somewhat improved after 3 weeks. Reduced range of motion. Reported to pcp, pcp thinks vaccine was placed improperly
nurse called to inform that a 2-year-old patient received a dose of Kinrix back in 7/Sep/2023. It was the first dTap and IPV dose for the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J) for prophylaxis.   On 07-SEP-2023, the patient received the 1st dose of Kinrix. On 07-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: nurse called to inform that a 2-year-old patient received a dose of Kinrix back in 7/Sep/2023. It was the first dTap and IPV dose for the patient).The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter called to inform that a 2-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. It was the first dTap and IPV dose for the patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
PT COMPLAINED OF NAUSEA ABOUT 20 MINUTES AFTER ADMINISTRATION OF PNEUMOVAX23 AND FLUZONE HD. SHE SAT DOWN TO EAT LUNCH AND BECAME NAUSEAUS. SHE LAID DOWN AND TOOK A NAP. WOKE UP FEELING BETTER WITH NO NAUSEA.
Within 11 minutes of receiving my first dose of the Covid-19 vaccine, I became extremely hot and started sweating. My face turned bright red and my heart rate increased to 152 beats per minute.  My respirations became very labored and my blood pressure was 187/97. I was monitored for 30 minutes afterwards. The nurse placed ice packs on the back of my neck to cool down. She continually monitored my vital signs. Upon leaving my blood pressure was still elevated, but improved.