chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am still itching more severely/My legs specially are itching; got a rash and going on all over my body way from my legs and throughout my back/so my entire body almost has a rash; My legs specially are itching and dry/that I am a dried up old lady; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had Covid", start date: Jul2021 (unspecified if ongoing), notes: I had Covid Jul2021 after I cleared the infection and recovered. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (2ND DOSE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd Booster, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (4th booster, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (1st dose, Itching), for COVID-19 immunization, reaction(s): "Itching"; Bnt162b2 (1st dose, I have got a rash and going on all over my body way from my legs and throughout my back), for COVID-19 immunization, reaction(s): "I have got a rash and going on all over my body way from my legs and throughout my back"; Bnt162b2 (1st dose, thought it was a dry skin), for COVID-19 immunization, reaction(s): "thought it was a dry skin". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "I am still itching more severely/My legs specially are itching"; RASH (non-serious), outcome "unknown", described as "got a rash and going on all over my body way from my legs and throughout my back/so my entire body almost has a rash"; DRY SKIN (non-serious), outcome "unknown", described as "My legs specially are itching and dry/that I am a dried up old lady". Therapeutic measures were taken as a result of pruritus, rash, dry skin.  Additional information: Patient had been on a blood thinner for weeks. Ever since patient got the vaccine, after having disease, she had Covid "Jul2021" after it cleared the infection and recovered, she got the vaccine. After she got the first Pfizer vaccine patient started itching and couldn't figure out, thought it was a dry skin also had a rash ever since she got the vaccine. Patient (today) went and got her 5th booster needless to say, still itching more severely entire body almost had a rash. Her legs specially were itching and dry and realized that she was dried up like old lady. Patient had been using Cortisol (Intent: Treatment) and she just wanted to report the itching and the body rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201188044 same product, patient, different AEs, different dose;
Information has been received from a certified medical assistant concerning a female patient (age not reported) who, on an unspecified date, was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649695/0512P). Subsequently, on an unspecified date, the patient developed an injection site reaction including swelling, redness, and pain. The patient was treated with ibuprofen and warm and cool compresses. At the time of the report, it was unknown if the patient had recovered. The reporter indicated that it was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past. There was no product quality complaint involved. Additional information has been requested.
vaccine was administered today, 11-8-21 that expired 11-7-21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21) 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 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   Reporter did not allow further contact
2nd dose on 10/7/2021, first on 06/28/2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received HBV (Engerix B) (batch number bg92z, expiry date 4th July 2022) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 28th June 2021).   On 7th October 2021, the patient received the 2nd dose of Engerix B. On 7th October 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Engerix B later than the recommended schedule which led to lengthening of vaccination schedule. Healthcare professional did not provide address or email. The reporter consented to follow up.
diagnosed with Covid/tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with Covid/tested positive) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 016C21A and 040B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosed with Covid/tested positive). At the time of the report, COVID-19 (diagnosed with Covid/tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2022, SARS-CoV-2 test: (Positive) positive. On 09-Sep-2022, SARS-CoV-2 test: (Positive) positive. On 10-Sep-2022, SARS-CoV-2 test: (Positive) positive. In September 2022, Pyrexia: 97.5 degree Celsius.         No concomitant medications was reported.  The patient tested positive this past Thursday and then had a fever these last two days and then dropped back down to 97.5 degrees. The patient was slightly congested.  No treatment medications was reported.  Company Comment: This is a spontaneous case concerning a 38-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 10 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have fever and slightly congested. Clinical course and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 38-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 10 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have fever and slightly congested. Clinical course and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a consumer concerning her approximately 4 year old son with seasonal allergy and a history of developmental delay, sickness, breathing difficulty, abnormal behavior (spinning in circles, "acted autistic") after prior therapy with all of his shots (names and manufacturers unspecified) that are required the first year of life (WAES # 0904USA03747) who on an unspecified date was vaccinated with VARIVAX (Merck). Subsequently, on an unspecified date, the patient experienced seizures. The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Follow up information was received from a medical assistant. On 26-SEP-2006 the patient was vaccinated with VARIVAX (Merck) (lot # 649740/0221R). It was reported the patient was first seen in their office on 21-NOV-2006. Upon internal review, seizures was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Per mom, 1 hr after admin, developed erythema at site of varicella injection. Increased in size x 1 day. Saw DR 11/2/11 - given antibiotic & told to give TYLENOL or Ibuprofen.
76 YO M WHO HAD JUST RECIEVED HIS FIRST COVID VACCINATION WAS IN THE OBSERVATION AREA POST-SHOT WHEN HE BEAG TO C/O OF CHEST DISCOMFORT THAT WAS DESCRIBED AS A BURNING PAIN FROM THE TOP OF THE STERNAL NOTCH TO THE XIPHOID PROCESS IN A STRIP. PT ALSO HAS RADIATION TO NECK AND IS SOB, AND SLIGHTLY SWEATY. PX DESCRIBED AS 4-5/10 AND HAD THIS PAIN FOR APPROXIMATELY 20 MINUTES BEFORE REQUESTING ASSISTANCE. NOTHING MAKES PAIN BETTER OR WORSE. PT SITTING A/O X4 IN NO OBV DISTRESS. HEENT - PERRL, NO JVD, SPEAKS IN FULL SENTENCES. CX - LS =/CLEAR, EKG ST WITHOUT ECTOPY. M-6 PERFORMED 12 LEAD AFTER PT TRANSFERRED TO THEM FOR TRANSPORT. EXTREM - PWD, GOOD PMS X4 Pt transported to ED
102 degree fever, chills, shakes, sweats, fatigue, nausea, headache. Only used Tylenol, resolved after about 40 hours.
Adult 12+ Covid 19 bivalent vaccine is given to 5 years old child.
Pt brought by caregiver for acute onset rash Lt shoulder. Received DTaP at that site 10/07/08. Pt c/o itching immunization site. Skin exam notable for pmt to slight erythematous patch approx. 1.5" diameter left should, non-tender, no signs of bacterial super-infection.
redness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema 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 erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was asking how many days required for redness to disappear after the shingles injection. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Third dose Anthrax. Site was swollen, sore, itchy and red. Mild warmth to area with erythematous rash.Sore throat, post nasal drip, nasal discharge.  Fever and chills last night. URI w/sinus congestion.Sx lasted 2-3 days.Tx w/Benadryl.
Rapid heart rate, ringing in ears, dizziness, tightness in chest, high blood pressure, cramping in toes, occasional tingling in fingers
Information has been received from a registered nurse (RN) concerning a 4-year-old overweight female with a history of a streptoccal infection who on 23-JUN-2006 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot #643768/1063M). The RN reported that on 14-NOV-2006, the patient developed breakthrough chickenpox characterized by 50-249 lesions on her face, back, neck,chest, abdomen and right wrist. The vesicles were also noted to be on the roof of her mouth. Unspecified medical attention was sought and the patient was ordered diphendramine HCL (BENEDRYL), cool compresses and acyclovir. As of 16-NOV-2006, the patient was recovering as she was noted to be doing better. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In or around 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, strength, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of shingles to be disability.
Menactra as a subcutaneous injection today in the right arm / no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old male patient who received 0.5 ml vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6179AA (Expiry date 29-Mar-2020) via subcutaneous route in the left arm, on 09- Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination.  It was reported that Menactra as a subcutaneous injection today in the right arm.  At a time of reporting no adverse effect 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
Fever - Information has been received from a physician concerning 4 patients who in march 2001 were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 637423/1512k.  In march 2001, the patient experienced high fever or greater than 102F.  unspecified medical attention was sought.  additional information has been requested.
Excursion occurred on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes; No adverse event; Patient was given expired vaccine on 30-Mar-2023; Patient was administered the vaccine that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the vaccine that had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 30-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired vaccine on 30-Mar-2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the vaccine that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the vaccine that had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the vaccine that had undergone temperature excursion).    No concomitant medications were provided. The vial had undergone temperature excursions on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes. The vial was initially stored in the refrigerator on 29-Mar-2023.  No treatment medications were reported. This case contains information for the 2nd of 2 adult patients who received the vaccine on 30-Mar-2023 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718070 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718070:Master case-(1st adult patient vaccine administer on 27Mar2023)
No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that aricella virus vaccine live (oka/merck) (VARIVAX) was under temperature excursion (TE) on at 8.42 Fahrenheit degree 1 hour 2 minutes. On 28-JUL-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot # U015847, expiration date: 19-MAY-2023, for prophylaxis (strength, dose, and route of administration were not provided) (product storage error). There was no additional adverse event (no adverse event).
Fever 102.3F, weak and unable to stand, chills, difficulty breathing; went to ER for evaluation, coronary monitoring, chest x-ray, hydration
No additional AE; called to report that a dose of VARIVAX was inadvertently administered after suffering a TE. The supported TE case number is 02474995. No additional AE/PQC.  ?    Names of vaccines involved (including lot/exp) VARIVAX  X001000  1/9/2025; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.       On 19-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X001000 and expiration date 09-JAN-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product storage error and no adverse event). The time excursion lasted 19 minutes in temperature of -12.1 Celsius degree.
rash and itching; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 50 years old female patient who experienced rash and itching, while she received vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Nurse states patient was unsure of which Tdap she received that caused the reaction).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious rash and itching (rash pruritic) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  No lab test reported.  Final diagnosis was rash and itching.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported.  Information on the batch number was requested
Client received higher dose Fluzone vaccie (0.7ML) instead of Flaurix(0.5ML) Vaccine. No adverse effect noted at time of adminsitration.
The pain from left deltoid down to the toes and right hand middle fingers joins are so painful.  Two days later the pain extended to the neck pain.