chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In January 2003, pt was due to be deployed. He was screened for his first anthrax vaccine and SPV (revaccine). He informed the physician that he was taking medications for DM and HTN and was told that he should do fine. He received both vaccines on 4Feb03 in separate arms. Within 24 hours he developed flu like symptoms (body aches, headaches, fatigue), that lasted approximately 4-5 days. The vaccination site of the anthrax vaccine was slightly swollen and tneder to palpation (2 inches surrounding) with a small nodule at the site. The smallpox vaccination site was determined to be a major reaction around day 7. Approx 7-10 days following the vaccines, pt got up early to get ready for work. While in the shower he began seeing 2 big yellow spots; he could not see his hand directly in front of his eyes; if he closed one eye he saw 1 yellow spot; could see a little in the extreme peripheral fields. He stood still for a few minutes and the spots gradually started to diminish and totally disappeared within 5-8 minutes from onset. After he got off the ship (a couple weeks later), he went to see an ophthalmologist and was told his exam was normal. He was also seen by the union doctor and was told nothing was wrong. He has had not recurrence of similar visual changes. He has no history of eye disease.
13 adult patients in one internal medicine practice site were administered Daptacel brand of DTaP in lieu of Adacel (Tdap). An adolescent in a second pediatric practice site was administered a different brand of DTaP. The nomenclature of DTaP and Tdap is confusing and introduces a risk for error, which will only increase as new vaccinations are introduced. The similarity in the brand names Daptacel and Adacel is a further significant contributing factor to this error as it affected 13 adult patients. It appears that in fact the internal medicine practice ordered Adacel from the supplier and Daptacel was shipped, and this error was not identified until 13 patients were administered this vaccine. All 14 affected patients were contacted. None had any unusual vaccine reactions. The error was discovered when one of the nurses administering the vaccine noticed that it was not Adacel. The practice has notified all physicians and site managers about the error(s), and have verified that there all sites that need Adacel have it. Our family practice and pediatric sites have other brands of DTaP, but we will be on the lookout for Daptacel as we get shipments of DTaP, since it is multi-sourced.
Narrative: Hospitalization - admitted for right-side weakness and found to have left occipital lobe intraparenchymal hemorrhage. Incidentally found to be COVID-positive on admission, asymptomatic. Fully vaccinated (not boosted). Pt died on 2/7/22 2/2 CVA.
Nurse reporting PROQUAD was administered after a temperature excursion. No additional AE. No PQC.; Nurse reporting PROQUAD was administered after a temperature excursion. No additional AE. No PQC.; This spontaneous report was received from a a registered nurse referring to a patient of unknow age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 mL as prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported; valid lot number U029321 with expiration date 19-MAR-2023). The administered dose of the vaccine experienced a temperature excursion -12 degrees Celsius (C) for 24 hours. There were no previous temperature excursions before, adverse effects, or product quality complaints (PQC).
Blisters in mouth/mouth broke out in blisters; mouth broke out in blisters and is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in May 2021. Concomitant products included AMLODIPINE for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore). At the time of the report, ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for pneumonia one week before vaccine and received antibiotics for treatment of the pneumonia. Patient then took oral antibiotic for treatment of the rash and blisters too. Patient has appointment with her primary care doctor 03-Jun-2021.
Pain at injection site Tiredness Headache Muscle pain Chills Fever Nausea
This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in eye in a 36-year-old female patient who received ENGERIX B (batch number 2KJ42, expiry date 7th April 2019). On 15th November 2017, the patient received ENGERIX B. On 15th November 2017, less than a day after receiving ENGERIX B, the patient experienced burning sensation in the eye, exposure via eye contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning sensation in eye, exposure via eye contact and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning sensation in eye to be related to ENGERIX B. Additional details were provided as follows: The patient while receiving ENGERIX B, some of the vaccine accidentally squirted into an health care professional's eye which led to inadvertent exposure to vaccine and exposure via eye contact. The health care professional flushed her eye with saline, and experienced burning in her eye which continued 30 minutes after the accidental exposure and was ongoing at the time of the report. This was an accidental medication error without harm. Follow up information received from other healthcare professional who was physician assistant on 11th January 2018: The reporter's details were updated. The patient used artificial tears in affected eye for 24 hours and the day following exposure, the patient's eye was back to normal. The VAERS details were updated.
This case was considered medically important (OMIC). Information regarding Prevnar vaccine was received from a consumer regarding a 18 month old male patient who reportedly exhibited some symptoms of Autism. The symptoms were reported as pronounced speech delay, a tendency not to verbally communicate with others, issues with motor development and diarrhea. At 6 months of age, the patient received a dose on 11/10/03. The patient also received a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine on 11/10/03. The patient has a past history of jaundice occurring right after birth. Indication for Prevnar was immunization. Product was administered on 11/10/03. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The mother of the patient reported that on an unspecified date in November 2004, at approximately 18 months of age, her son exhibited some symptoms of Autism but has not been diagnosed. The patient's symptoms were reported as pronounced speech delay, tendency not to communicate with others verbally, issues with motor development, and diarrhea. The patient has not recovered. No additional information was available at the time of this report.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
administrated Menveo with another diluent; administrated Menveo with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number amva676a, expiry date 31st March 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The director of operation reported that the multiple patient were administrated with the powder of Menveo with another diluent between 6th July 2022 and 7th July 2022. No adverse event reported.  The reporter did not know how many patient were administrated with this lot number. No patient's identifiers provided. The reporter consented to follow up. Additional supportive information: The director of operation reported that the multiple patient were administrated with the powder of Menveo with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with case US2022106108, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106108:Same report, diferent lot number
DID NOT TAKE THE FOURTH DOSE OF VIVOTIF AS CAPSULE WAS BROKEN AND THE CONTENTS WERE MISSING; This spontaneous case report (PVX2019-2947, PTC-000105) was received from a pharmacist on 02-Dec-2019. It described a female consumer who "did not take the fourth dose of Vivotif as capsule was broken and the contents were missing" (PT: Incomplete course of vaccination). She was receiving Vivotif capsule (lot number: 3003303; expiry date: Sep 2020) for typhoid prophylaxis.  Case report: The consumer had taken three doses of Vivotif and the third dose was taken either on 24-Nov-2019 or 25-Nov-2019. Then, she noticed that the fourth capsule was broken and the contents were missing. Thus, she did not take the last dose. It was reported that she will be traveling to the endemic area on 12-Dec-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer did not take the fourth dose of Vivotif as capsule was broken and the contents were missing (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer did not take the fourth dose of Vivotif as capsule was broken and the contents were missing ( Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
No additional AEs were reported.; patient received an expired MMRII vaccine today 9/7/2022.; This spontaneous report was received from a medical assistant referring to a 15-year-old patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported. The patient's concomitant medications included sterile diluent (manufacturer unknown).   On 07-SEP-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 1 dose, lot number T027935, expiration date: 18-AUG-2022, administered subcutaneously for prophylaxis (dose was not provided) (expired product administered).  No additional adverse event (AE) information was provided (no adverse event).
pt recv vax & devel an inj site rxn characterized by swelling, redness, itching & warmth;
Other complications following immunization, not elsewhere classified, initial encounter on 2020-12-29.
Starting that day about 20minutes after the vaccine I got severe stomach cramps which culminated in vomiting diarehea and migraine and other typical symptoms like achy muscles and dizziness but those went away by the 2/3rd day. But the vomiting and diarrhea hasn't gone away and its be like a month. On the 6th I went to the ER and they tested me for a wide variety of things and didn't find anything and sent me home. I went to the walk in the next morning and they tested for the same things to include stool, urine and blood samples. they didn't find anything. a week went by and it didn't get any better. they said it was probly a virus i got the same day. i wasn't getting any better but vomiting and stomach cramps were getting worse. went back to the ER and they did ct scans and checked my gallbladder and appendix and they didn't find anything. went to my Doctor and they sent me to the GI doctor because they didn't find anything. The GI doctor I went to last week is sending me to do a colonoscopy and endoscopy next week. stomach cramps are so severe that i throw up and have lost 20-25 pounds over this last month since i'm unable to eat anything. Again the normal typical symptoms only lasted 3 days. but the other gi issues have persisted.
Within 6-8 minutes of receiving vaccine, looked at cell phone to text husband and could not focus on the keys (Blurred vision), then felt a rush/tingling sensation thru whole body, as if the medication starting/moving from my arm all the way down my legs, some dizziness and heart rate increased - I believe to 120.  No increased BP, SOB, itchiness, closed throat feeling, hives.  Heart felt like it was racing for about 10 minutes.  RN at site checked BP and heart rate 5 times in 40 minutes.  Left facility and was able to drive myself home.  Later that evening, soreness at injection site for 36 hours.  No fever, chills, body aches.
Patient received her SHINGRIX on Saturday. She felt fine on Saturday but on Sunday was fatigued, ran a low grade fever, & her arm was slightly swollen & sore. She was not concerned about these symptoms being that the VIS states them as possible adverse events. But then on Wednesday evening, she developed slight redness & itching around the injection site. She came into the pharmacy on Thursday to inquire about it. The patient states that the itching is a 1-2 on a scale of 10 & the redness spread out about an inch or two from injection site. I ( the pharmacist) plan to follow up with her to see if the rash resolves but even though it was a mild reaction I  thought it best to report rather than not.
Chills, 102 fever, jack-hammering headaches, body aches, chest pain, dizziness, plugged ears, stiff harm, sore lymph nodes. All finally went away after day 5 except still have chest pains.
Patient had syncopal episode within 10 minutes of vaccination.  Patient felt better after drinking some water and was released to home.
12 hours later symptoms of- diarrhea, severe vomiting, chills, body aches, fatigue, light/touch/sound sensitivity, dizziness 24 hours later symptoms continued except for diarrhea and vomiting. New symptoms of heart palpitations, dizziness, difficulty taking deep breaths, continued sxs of light/sound sensitivity, body aches, fatigue, night sweats 48 hours later- most symptoms better but continued fatigue, difficulty taking deep breaths, heart palpitations, night sweats
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna/ Vaccine dose number=1/2/3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 007M20A), in right arm, on 25Jan2021 as dose 2, single (Lot number: 023M20A), in right arm, on 30Oct2021 as dose 3 (booster), single (Lot number: 939903), in right arm and on 02Sep2022 as dose 5 (booster), single (Lot number: AS7140C), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetanus toxoid for known allergies tetanus toxoid. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine dose number=1/2/3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Feb2023) Negative, notes: Finished paxlovid course (no missed doses) 24Feb. Tested negative the next day; (07Mar2023) Positive, notes: retested positive 07Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid.
Information has been received from a concerning a 50 year old nurse female who was also a nurse was vaccinated with a dose of ZOSTAVAX (Oka/Merck), lot number: 662755/1621X. The patient experienced shingles after receiving the vaccine. She developed rash on her upper neck, blisters and pain on the right side only from the back of her neck. No further information was provided. Subsequently the patient recovered. The patient sought medical attention. Shingles was considered to be disabling by the nurse. Additional information has been requested.
Patient is having blurry vision and double vision in the afternoons. Patient was not able to read the LOT number.
Rigidity in joints upon rising; collapse n total loss muscle control by 5pm that day (recovered 11 pm that nite)
This case was reported by a healthcare professional and described the occurrence of mark at injection site in a 35 year old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included TWINRIX (Glaxosmithkline) given in the left arm on 23 February 2009 at 10:00. Concurrent medications included DEPOPROVERA.  On an unspecified date approximately one month ago, the subject received 1st dose of TWINRIX in the left arm. Soon after vaccination with TWINRIX, the subject developed a hole at the injection site and skin discoloration where the bandage was attached. The hole and the discoloration were unresolved at the time of reporting. The subject stated that the area was not painful and did not bother her. No bandage was applied after the 2nd injection in the same arm. It was noted that the reporter initially reported that the events took place following the 2nd administration with TWINRIX. She then corrected to say it was the 1st injection that triggered the events.
Information has been received from a medical assistant concerning a 14 month old patient who was vaccinated inadvertently with a dose of ZOSTAVAX (Oka/Merck) (lot #663194/1415X) and a dose of VARIVAX (lot # 662129/1752X) on the same day due to human error.  No adverse effect reported.  Follow-up information was received from the medical assistant.  It was reported that the 14 month old male child was suppose to received MMR II instead of ZOSTAVAX (Oka/Merck).  There was confusion between the 2 vaccines because both lids were red.  Follow-up information was received from the medical assistant.  It was reported that on 02-FEB-2008, the 15 month old male child with lactose intolerant and no illness at time of vaccination was vaccinated with a dose of ZOSTAVAX (lot # 663194/1415X) into the left thigh and the first dose of VARIVAX (lot # 662129/1752X) into the right thigh.  No symptoms reported.  No further information is available. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from the medical assistant.  It was reported that on 05-FEB-2008, the 15 month old male child with lactose intolerant was vaccinated with the first dose of ZOSTAVAX (Merck) (lot #663194/1415X) into the left thigh and was vaccinated SC with the first dose of VARIVAX (lot # 662129/1752X) into the right thigh.  No reactions reported.  No further information is available.
Pt given a series of 3 MSD Hep-B vaccines, & 2 Engerix-B vaccines due to being non responder. Pt developed encephalitis & died. Herpes varicella recovered form brain
Per the patient, she received the vaccine with her PCP. She claimed that she developed the following on  the day of vaccination - headaches, nausea, vomiting, hot flush, sweating ,and bones are achy. Patient / employee claimed that the above symptoms continued to manifest and became worse on August 13, 2021.
This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. Case Number: 00607615. A contactable pharmacist reported that patient of unspecified age ethnicity and gender received PREVNAR 13, lot number and expiration date not provided, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash (non-serious) on an unspecified date with outcome of unknown. This information has not been reported to the FDA. No follow-up attempts are possible. No further information is expected.
I had chills, muscle pain, joint pain but the reason I am reporting is I had a fever of 101 degrees Fahrenheit.
A report has been received from a Health Professional concerning a patient born on 25-Jul-2013, female subject, who had been receiving FLUMIST, 0.2 Millilitres, unknown. FLUMIST started on an unknown date. The patient experienced rash. The outcome of the event of rash is unknown. The report was considered to be non-serious.
This spontaneous report was received from a health care professional refers to a female teenager patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, frequency, lot # unspecified). Concomitant therapy was not reported. On an unknown date the reporter read a posting on social media that discuseed an unspecified teenage girl developing Lymes disease after receiving GARDASIL. Vaccine on an unspecified date. No further information provided. The outcome of Lymes disease was unknown. Causality assessment was not reported. Additional information was not reported. Additional information has been requested.
Extreme joint pain in shoulders, elbows, wrists on both arms. This is the 2nd time I?ve experienced these symptoms/ 1st time was 4th shot. Same brand.