chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of idiopathic transverse myelitis in a 11-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). 30 days after vaccination with DTPa (with small D + P), the subject experienced paraplegia at the T10-T11 level. The subject was hospitalised and was diagnosed with idiopathic transverse myelitis. At the time of reporting, the outcome of the events was unspecified. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
father called c/o child being grey-first color red then purple then gray; shrill cry then period of apnea for seconds; eyes rolling, unable to support head;
This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 19-year-old female patient who received BEXSERO. In June 2016, the patient received BEXSERO .5 ml. In June 2016, less than a month after receiving BEXSERO, the patient experienced muscle pain, rash and numbness. In June 2016, the outcome of the muscle pain, rash and numbness were recovered/resolved. It was unknown if the reporter considered the muscle pain, rash and numbness to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccine administration was not reported. Sales representative called to report that a physician reported to the sales representative that within the last two weeks in the doctor's office, the patient was vaccinated with BEXSERO. Soon after that the patient had muscle pain, rash, and numbness which got better in about 3-4 days and then which was resolved.
pt recvd vax & devel acute demyelinating encephalomyelitis & was hospitalized;MD reported another pt w/same exp;
Noted redness and swelling the morning after injection 50 cent size but next day red about 10 inches and said could not lift arm.  Also had TDAP in same arm as VARIVAX.
Patient complaining of soreness and numbness/tingling of the upper left shoulder from 10/3/12.
syringe is leaking out some of the content in the syringe; did not get all that he suppose to get; A spontaneous report  was received from a reporter concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe leaking contents while administration and did not get all that he was supposed to.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, while receiving the vaccine the patient experienced syringe leaking contents and did not get all that he was supposed to. Patient was referred to his health care professional.  Action taken with mRNA-1273 in response to the events was not reported  The events syringe leaking contents while administration and did not get all that he was supposed to, was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # 010M20A.  There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.
Multiple syncope episodes, fever for 24 hours, low blood pressure, chills, sweating
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L042817, exp. 26-APR-2017, dose and route of administration was unknown). No concomitant therapy was unknown. The vaccines was exposed to an unspecified number of defrost cycles which went up to maximum of 14.7 F. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
This is a spontaneous report from a contactable medical assistant reported through a Pfizer sales representative. This medical assistant reported similar events for two patients. This is the first of two reports. A patient of unspecified age, race/ethnicity and gender received TRUMENBA (Lot number 526962), intramuscular at single dose in the right arm on 13Jul2017 for immunisation. The patient medical history was not reported. Concomitant medication included HPV vaccine intramuscular in the left arm on 13Jul2017 for immunisation. On 14Jul2017, the patient experienced a more swollen than normal injection site reaction. In additional, there were three horizontal lines under the injection site. The caller believed that the lines were red lines. The outcome of the events was unknown.
FEVER, CHILLS, HEADACE, FLU-LIKE SYMPTOMS FOR 18 HOURS AFTER VACCINATION
Severe stomach pain; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMLODIPINE; VENLAFAXINE; PROGESTERON. Past drug history included: Augmentin, reaction(s): "Allergy"; Hctz, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 19May2022 at 21:00, outcome "not recovered", described as "Severe stomach pain". Therapeutic measures were not taken as a result of abdominal pain upper.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, Muscle Aches, Chills, Headache, Nausea, Vomiting, Diarrhea
This case was reported by a nurse via sales rep and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fatigue, myalgia, sleep excessive and activities of daily living impaired. On an unknown date, the outcome of the headache, fatigue, sleep excessive and activities of daily living impaired were recovered/resolved and the outcome of the myalgia was unknown. It was unknown if the reporter considered the headache, fatigue, myalgia, sleep excessive and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. Within 2 hours after the vaccination, the patient experienced headache. The patient normally did not have headache. The patient slept most of that afternoon and fatigue to the point of not being able to do anything. The patient also experienced myalgia and slept 12 hours the next day. The all symptoms resolved within 3 days. The reporter agreed to be follow up from GlaxoSmithKline.
Patient received Anthrax vaccine among other vaccinations on 7/6/06. On 7/8/06 began having sx. of scratchy throat, diarrhea, and low grade fever with temp up to 101.1. 7/11/06 returned to clinic with continuation of sx. Low grade temperature of 99.3. Vaccination site R anterior upper arm with 1 by 1.5 inch dark erythematous area and 3 by 3.5 inch light erythematous area present with mild swelling. Diagnosed with URI and Anthrax reaction. Placed on quarters for 48 hours, Tessalon pearls and Immodium prescribed. To RTC 13July06 for follow up.
ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP  PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN  DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.
Two hours after vaccine ulnar nerve paralysis of right hand; INFLUENZA VACCINE given on 18Oct2022; INFLUENZA VACCINE given on 18Oct2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 18Oct2022 at 16:30 as dose 4 (booster), single (Lot number: FT9142) at the age of 58 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Oct2022 as dose 1, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "OSA" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "INFLUENZA VACCINE given on 18Oct2022"; ULNAR NERVE PALSY (disability) with onset 18Oct2022 at 18:30, outcome "not recovered", described as "Two hours after vaccine ulnar nerve paralysis of right hand". The event "two hours after vaccine ulnar nerve paralysis of right hand" required physician office visit. Therapeutic measures were taken as a result of ulnar nerve palsy.  Clinical course: Other medications in two weeks: Allopurinol, Mounjaro, ibuprofen. Medrol dose pack was used to treat ulnar nerve paralysis of right hand. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the even ULNAR NERVE PALSY and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt ran t103.4 from 5PM-9AM (12hr) mom called ER; nurse stated mom to continue giving APAP every 3 hrs & to given luke warm bath; MD called p/bath temp subsided 1 1/2hr; pt was feverish for 2 days though temp was not as high;
15 hours after vaccination, patient awoke unable to walk due to pain in left knee. X ray demonstrates small effusion in left hip. to see orthopedics.
This spontaneous prospective pregnancy report received from a consumer referred to a 28 year old female patient. The patient's current condition included allergy to many unspecified antibiotics. Medical history and concomitant medications were not reported. The patient received the VARIVAX on 14-NOV-2016 and the patient found out on 14-DEC-2016, that she was pregnant. Because the product information for VARIVAX states that pregnancy should be avoided for 3 months a full AE is being reported. The Last Menstrual period (LMP) date is 01-DEC-2016 and the due date is 07-SEP-2017. Additional information has been requested.
Patient with onset of erythema and slight swelling of Left deltoid area 1 day after vaccine adminstration.  Patient with full use of left arm/hand, no limitation of activities.  Patient without fever, vomiting, diarrhea, or other systemic symptoms.  Patient had a 4.5 inch x 5.25 inch area of blanching erythema on left deltoid.  No evidence of pustule or discharge.
suicidal tendencies; severe  depression; extremely enlarged breasts; Prolonged period; extreme fatigue; severe hormonal acne outbreak waist up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 13:45 as dose 1, single (Lot number: FC3594) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thoracic Outlet Syndrome" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; TESTOSTERONE CIPIONATE. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid"; Darvocet, reaction(s): "Known allergies: Darvocet"; Doxycycline, reaction(s): "Known allergies: Doxycycline"; Z-pak, reaction(s): "Known allergies: z-pak". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "Prolonged period"; FATIGUE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extreme fatigue"; BREAST ENLARGEMENT (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extremely enlarged breasts"; DEPRESSION (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe  depression"; ACNE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe hormonal acne outbreak waist up"; SUICIDAL IDEATION (medically significant) with onset 10Dec2021 at 12:00, outcome "unknown", described as "suicidal tendencies". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of suicidal ideation, depression, breast enlargement, heavy menstrual bleeding, fatigue, acne.  Additional information: No other vaccine in four weeks. No covid prior vaccination.  Follow-up (18Apr2022): Follow-up attempts are completed. No further information is expected.
Mild muscle ache; Mild chills; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 041L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache). On 10-Dec-2021, MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache) had resolved.            Concomitant medications were not reported.  On 10-Dec-2021, the patient received the first booster dose of Moderna vaccine.  The patient experienced the adverse events for 5 hours and it did not felt as bad as after the previous Moderna vaccine dose.  The patient had informed the physician about the reactions and had not taken any medicine.   This case was linked to MOD-2022-557486, MOD-2022-557682, MOD-2022-557549 (Patient Link).
Shingrix vaccine over a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year ago).   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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable. Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter asked that If a person had their first Shingrix vaccine over a year ago, could they get their second dose now or did they need to start the series over. The follow-up would not possible as no contact details were available.
FLU LIKE S/S  NEXT 2 DAYS FOLLOWED BY FATIGUE CONTINUING TO TODAY
The pt experienced a bronchospasm and urticaria within 24 hours of receiving the vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-JUL-2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In November 2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
I woke up in the middle of the night with sever chills. My body was shaking uncontrollably. I took an ibuprofen and then took a 40 minute hot shower. My chest felt tight and I couldn?t catch my breath, so I called 911 for extra precaution. My vitals were good so I was advised to take ibuprofen and stay hydrated. This chills, achy body, headache lasted the whole day. Chills, headache, body aches. It wasn?t until about 48 hours after the shot that I began to feel better.
intractable nausea vomiting requiring care in emergency room, about 48 hours after vaccination. mailaise fatigue, could not tolrate diet