chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus -Endocrine posted with recurrent DKA and insulin pump status.  Diabetic educator posted and educated about her insulin and carb count.  Dietitian posted for gastroparesis diet and malnutrition, and low fiber/low residual diet per Dietitian recs.  Speech posted for dysphagia and suggested GI consults with her ongoing DM/malnutrition issue.  Underwent EGD and dilatation for Mild Schatzki ring. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Lightheaded, dizziness, feeling warm developing after patient discharged from clinic prior to leaving facility, approximately 0825-0830. Returned to COVID vaccine clinic for assessment. Provided water, snack. Vs 0840: 163/86, HR 56, RR 18, 02 100%. States had not eaten this am, history of hypoglycemia.  0850: 160/75, HR 48-52, RR 18, 02 100%. States not feeling as warm but with increased dizziness. PT advised ER for further eval. Transferred to ER with staff.
Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 65-year-old male patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 11-JUN-2015, at the age of 64 years old (also reported as 54 years old, conflicting information), the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy for prophylaxis. As a result of his receipt or zoster vaccine live (ZOSTAVAX), on 06-JAN-2016, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), he 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 patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are 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 he requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, he requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. He also has suffered and will 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 patient's direct medical losses and costs include physician care, monitoring, and treatment. He has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
PATIENT RECEIVED 0.5MLS INSTEAD OF 0.25MLS  OF VACCINE
Patient with history of TIA one week prior presented to the ED for recent onset of fever and epigastric abdominal pain. Pt found to have calculus of bile duct with acute cholecystitis and obstruction. In Ed pt had fever as high as 104 and pulse as high as 129. The gallbladder was found to be distended  with wall thickening and large gallstone in the lumen. Patient transferred to tertiary care facility.
Eleven days after MMR child had severe rash to body-covering all body.  Child had fever 100-101 for 2 days.  Poor appetite.
Patient complained of shortness of breath, chest pain, dizziness, nausea and vomiting and dry mouth.  Patient only ate crackers and half granola bar since 4:30AM.    Blood pressure 220/120, anxious
Information has been received from a pharmacist via a field employee referring to a 65 year or older patient of unknown gender. The patient received PREVNAR two or three years ago. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date (reported as two or three years after receiving PREVNAR, the patient received vaccinated with PNEUMOVAX 23 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-395985 (Patient Link).
05/29/2005 started breaking out (vesicles).  Given antihistamines by doctor.
Very loud hissing/bee buzzing tinnitus in both ears. I have had mild tinnitus on and off over the past 10 years but not like this past year. It is a constant loud noise 24/7. I talked to my ear doctor about it last year and she explained there was no cure, damaged ear hairs, etc. I kept trying to think what I had done to bring this on then I started reading about all the other people who started experimenting tinnitus after their Covid vaccine. It definitely fits in my timeline. I kept thinking it would go away but it has not and it?s very disturbing.
Began within same day - Arm very swollen and red (Rt arm). Presented to pharmacy 3 days later, less swollen, but redness down to elbow and very painful.
Following injection pt reported feeling dizzy, sweating and appeared pale. No Syncope. Pt was put in a comfortable position. Provided juice, water & crackers and remained in office under close supervision for 20 minutes. Pt reported improvement in symptoms after 20 minutes and father of PT and clinical staff felt PT was safe to leave office. PT walked out of office on her own accord with mo
This spontaneous report as received from a registered nurse refers to a 36 years old female patient. On an unknown date the patient was vaccinated with an unspecified number of doses of M-M-R II, dose and route of administration were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had titers for rubella that were "equivocal". The nurse reported that because of this "equivocal" titer result the patient will need to receive another dose of M-M-R II. It was reported that the patient sought medical attention by an office visit. The nurse also mentioned that she has been seen in the past an unspecified number of female patient who are postpartum and have low rubella titers even though they have received an unspecified number of doses of MMR in the past (MARRS case # 1212USA003240, same reporter link). The outcome of has titers for rubella that are "equivocal" is unknown. The relatedness for has titers for rubella that are "equivocal" was no reported for M-M-R II. Additional information has been requested.
Fever of ranging from 100-100.7 from Friday evening and still continuing.  Not responsive to ibuprofen. Other symptoms include chills, aches, loss of appetite, nausea, weakness and fatigue
Flu like symptoms, achiness, fatigue, swelling at site of injection and subconjuctival hemorrhage one eye.
This spontaneous report as received from a pharmacist refers to an unspecified pharmacist of unknown age and unknown gender. None pertinent medical history and drug reactions or allergies were not reported. On an unknown date the pharmacist, during the administration of ZOSTAVAX 19400 PFU, (strength and lot number were unspecified), inadvertently dripped some of the reconstituted ZOSTAVAX vaccine on his hand. Following the exposure of ZOSTAVAX, the unspecified pharmacist developed shingles on that same area of his hand. Concomitant therapies and treatments given were not reported. The outcome of developed shingles was unknown. Additional information has been requested.
Patient states that a rash developed on her torso the day after getting her flu shot.  She claims the rash to be localized to the torso and has not spread anywhere else, reports no abnormal skin around the injection site.  Describes the rash as being red, not raised. Has not gotten any worse since the day after the vaccine but has not gotten any better either, this is day 4.  She will try benadryl and follow up with her physician if symptoms worsen or do not get better within the next day or two.
1 1/2" reddened area, slightly firm at injection site. Non tender, no itching, just noticed after shower.
Injection site swelling (golfball sized). Generalized pain and swelling from shoulder to elbow on side of injection.
Information has been received from a healthcare worker referring to multiple unspecified "18 or 19 year old" patient of unknown gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with an adult dose of RECOMBIVAX HB (lot#, dose and route not reported) which was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 16-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # N000326 with expiration date 14-OCT-2019 (strength, dose, frequency, route and anatomical location were not provided) and on 09-NOV-2017, the patient received the second dose of GARDASIL 9 intramuscularly, lot # N021571 with expiration date 29-APR-2020, both for prophylaxis. At the reporting time, there was no information about the third dose provided. The medical assistant reported that the second dose was administered 1 week too early according to the prescribing information. No adverse effect reported.
has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detaails were provided as follows: The age at vaccination was not applicable for thie report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was not sute about 1st dose of Vaccination date, because was at a different pharmacy. The reporter consented to follow up.
Regression of walking, unsteadiness standing and while cruising or stepping (improved 1/31) Tendency for falling backwards Intolerance of being brought down to supine position (resolved on 1/30) Reduced appetite for solids and reduced appetite for milk (improved 2/1) Irregular sleep pattern Fussy
Information has been received from a healthcare worker who worked at a state immunization program referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates these patients were vaccinated with doses of improperly stored MMR II (lot # K016154 with expiration 24-SEP-2016, dose and route were not reported). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
WHILE ADMINISTRING THE VACCINE THE LIQUID SHOT FROM AROUND THE NEEDLE OF THE SYRINGE AND SOME OF THE LIQUID WENT INTO THE PATIENT AND NURSES EYE. IT APPEARED NONE OF THE VACCINE WAS ENTERED INTO THE MUSCLE. MODERNA CONTACTED AND WAS TOLD TO REFER TO OUR PHYSICAN PROTOCAL .  PER OUR PHYSICAN WE WERE TO RE ADMINISTER THE VACCINE TO THE PATIENT.
Pain in right elbow and right forearm started three days after the dose and has been getting progressively worse over time.
At 8:58 am, injection attempt of 0.1 ml of Jynneos given intradermally in the right forearm resulted with the following incident: during injection of vaccine, client made a sudden jerk/startled movement which in turn resulted in the needle dislodging and approximately 1/2 of the vaccine dose not being administered. Wheal measured <3 mm, which is less than the requirement and remaining vaccine leaked out onto the vaccination table. Outcome: Client received the repeat dose of Jynneos Intradermally at 9:08 without incident.
Lt leg very swollen from hip to knee, Rt side of face swollen. Hives pm of 5Feb91.  BOM 6Feb91, Tx-Benadryl,Amoxicillin
I was attempting to give similar vaccines to siblings - I was teaming up with another nurse and accidentally administered the same vaccine that was given by my co-worker. Patient received 2 doses of DTaP.
approx 30hr p/vax pt exp brief <30sec tonic spell followed by a cry (abnormal);
no adverse event-fyi- multi dose diluent vial was drawn more than once to mix with covid vaccine
Large area of cellulitis over the right shoulder.  Confusion.  Pan cultured and started empirically on vanco.
Stomach Pain, Vomiting a lot, Diarrhea, chills....Once my body was cleared of fluids I was okay...It lasted about 3 to 4 hours.  Shot was at 1400hrs and side effects began around 1800hrs and over by 2100hrs or so.
Here 11-5-07 diagnosed chickenpox scattered pink papules with small vesicles some ex conated started on Friday 11-2-07.
blood pressure was super low (BP: 83/56); period started and it was the worst flow she have ever had/ lost over a cup of blood in 5 mins; extremely tired; mild to severe fever; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:30 (Lot Number: EN6203), at the age of 39-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included asthma, hypotension, allergies. The patient is not pregnant at the time of vaccination.  The patient did not have COVID-19 prior vaccination. Concomitant medications included fludrocortisone; diphenhydramine hydrochloride (BENADRYL); salbutamol (VENTOLIN); ergocalciferol (VIT D), all were taken for unspecified indication, start and stop date were not reported.  On 02Mar2021, the patient was extremely tired for the first 48 hours; the patient also had a mild to severe fever for 5 days. On 05Mar2021 1:00PM, the patient's period started and it was the worst flow she have ever had. The patient lost over a cup of blood in 5 mins, and had to change 4 pads within 1 half hour period. Thankfully after 2 hours of this. It stopped to a "normal" heavy flow; where I changed pads every 3-6 hrs. The next day, the patient was fine, but her blood pressure was super low (BP: 83/56). The patient reported this to her primary care physician. The patient was not tested for COVID-19 post vaccination. The outcome of the events extremely tired was recovered on 04Mar2021; the event 'mild to severe fever' was recovered on 07Mar2021; the event ' period started and it was the worst flow she have ever had/ lost over a cup of blood in 5 mins ' was recovered; the other event was unknown. Treatment was received for the events.
herpes/hepers 2; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection 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 herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: This case was reported by the patient. Patient stated had the Shingle Vaccine, since then had a blood test done and was diagnosed with herpes 2. Patient also asked would this be related to the Shingles shot. Reporter did not consented to follow up.
Pt reported blotchy redness at site of injection of Yellow Fever vaccine. No swelling or bumps. Approx. size 4.5cm wide, 2-3cm long. Pt noticed site on same day of vaccination 6/5/06. No general ill feelings noted. F/U on 6/14/06, no s/s present.
This spontaneous report as received from a healthcare worker (also reported as administrator) refers to a identifiable patient of unknown age. On 29-MAR-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 from lot N014946 expiry date 01-FEB-2019 for prophylaxis (Product storage error). No adverse effect reported. Temperature was reported as 52 degrees Fahrenheit. Time frame was reported as 4 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA008222.
tested positive for influenza; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 25-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, 1 week after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Approximately one week after vaccination patient tested positive for influenza via rapid test. The reporter did not consented to follow up.
This spontaneous report as received from a registered nurse refers to a 16 year old female patient. The patient had no medical history, no concomitant medication, and no drug allergy. On 20-NOV-2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly for vaccination. On 20-MAY-2013 the patient was vaccinated with an expired third dose of GARDASIL lot # 668261/1397AA, exp. date 09-APR-2013, 0.5 ml, intramuscular for vaccination. The patient experienced more burning than usual during the administration on 20-MAY-2013. The nurse reported that the "burning" quickly resolved and the patient "feels better now". Outcome of event was reported as recovered on 20-MAY-2013. No treatment was given. No lab test was done. The patient sought medical attention because the patient was at physician's office during administration. Additional information is not administration.
L deltoid distribution erythema, heat. Rx'd Keflex 250mg/5cc po quid.
Patient had syncopal episode and hit his head. He has a history of anxiety with needles. Patient was monitored by staff and was reported to be in stable condition. Patient declined ER transport and was released home.
Patient seen for rash (bumpy) on upper back trunk, buttocks.  Diagnose: Chicken Pox, 50 plus lesions, no school until lesion crust over.
headache; body aches; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced headache, general body pain and fever. On an unknown date, the outcome of the headache, general body pain and fever were unknown.   It was unknown if the reporter considered the headache, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and reported fever, body aches and headache. The reporter did not consent to follow up. The reporter did not want to provide any additional personal details about herself or the adverse events reported. The reporter did not get consent to follow up with HCP.
pt recv vax 30JAN97 & devel pain, swelling, & warmth in arm that extended from acromium process to just above the elbow;sx expanded to joint pain, h/a, 4 episodes of diarrhea & 2 episodes of vomiting;knot @ the inj site;