chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 36-month-old female patient who vaccinated with FLUZONE QUADRIVALENT (Batch number: UT6375NA, expiration date: 30-JUN-2019,0.5 ml dose, unknown route and left deltoid site of administration was reported) on 03-NOV-2018. It was also reported that, the patient received same suspect vaccine 0.5 ml in right deltoid on 16 Nov 2018. The patient's past medical history, medical treatment(s), and family history were not provided. It was reported that, the patient did not have any concomitant medication. It is an actual medication case error due to extra dose administered. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA  pain at injection site and surrounding area approx 15 hrs after injection (lasted 48 hrs) low grade fever approx 24 hrs after injection (lasted 24 hrs) body aches approx 24 hrs after injection (lasted 24 hrs) swollen lymph nodes in armpit on injection side approx 36 hrs after injection
Multiple system organ involvement immunocompromised; hospitalized with clotting and bleeding problems within 2 months. patient concurred this was a vaccine reaction.
Pt vaccinated w/Engerix-B developed feeling funny, inject site tender, chest pain, rt arm pain, rash at site of inject, sweating, medicine taste in mouth, excessive thirst, acute rx to vax, rt art leg tingling, felt cold, felt hot, chills.
pt recv vax 29MAY96 & 7JUN96 pt exp a measles-like rash on chest, arms, back & face;rash consisted of 2-3mm red, raised spots that were widely dispersed & not like chickenpox;the reporter felt the measles-like rash was r/t vax;
flu-like symptoms - fatigue, body aches, fever, headache, light-headed, stuffy nose, scratchy throat
Patient received the Pfizer Primary series instead of the intended Pfizer Bivalent third dose
Swelling, redness, tenderness, warm to touch at site of injection see in ER for treatment with predison and benadryl.
complained of her "tongue tingling" and her "head crawling" approximately 20 minutes after administration.  We initially administered 50 mg Benadryl, orally, vitals were BP 160/86, pulse 80, respirations 18.  After about 10 minutes, she complained that her entire mouth was numb and she was clearing her throat more, we administered one dose of Epi and called EMS. BP was 160/80, pulse 104, no difficulty breathing, just clearing her throat more.  EMS arrived approximately 5 minutes after Epi administered, evaluated the patient, and released the patient approximately 15 minutes later.  EMS stated vitals were normal and sensations in mouth were back to normal.  Patient stated she was returning to work here in .
trigger an underlying autoimmune disease; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was recovered/resolved.   The reporter considered the autoimmune disorder to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 1st one and then had it triggered an underlying autoimmune disease which no one could name. The patient stated six months of hell. The patient thought the shingles might had been easier. The patient's doctor said a lot of people had reactions to this vaccine. The patient stated that he/she was not saying not to get this but listen to your gut. The follow-up could not be possible as no contact details were available. The case had been linked with case US2021AMR232038, reported by same reporter.
This spontaneous report was received from a consumer (patient's mother) refers to a 15 year old female patient. The concurrent condition of the patient included exercise induced asthma and penicillin allergy. On an unknown date sometime in October 2014, the patient was vaccinated with dose 1 of GARDASIL (injection dose unknown) by an unspecified physician, Concomitant medications were unspecified. On an unknown date the patient was vaccinated with its second dose. On 13-APR-2015, the patient was vaccinated with third dose of GARDASIL at unspecified facility and by unspecified physician. After receiving the third dose of vaccine, the patient experienced fever, tremors, chills, a very bad headache, chest pains and shortness of breath. On 13-APR-2015, the patient visited to emergency room of unspecified physician and received TYLENOL (unspecified dose/frequency and manufacturer) for the treatment of the adverse events. The patient visited to same emergency room again on 14-APR-2015 and received MOTRIN and prednisone as treatment. On an unknown date, blood tests were performed, the results of which were unknown. It was confirmed that the patient received all the three doses of GARDASIL. The outcome of the events were reported as not recovered. Causality assessment was not provided. Additional information has been requested.
States arm got very sore to move, had limited range of motion.  She called Employee Health on 10/01/2015 and was still having pain and limited range of motion of left shoulder, pain and range of motion had improved but was still having problems.  She was seen at Occupational Health.
Shakiness at 9:00 PM on Friday, started running fever of 100.7 at about 3:00 AM which continued up and down for 2 days.  Started developing redness at injection site, which progressed the next couple of days until it circled my upper arm and a rash started to develop after the redness spread.  I still am experiencing some redness and the rash has not gone away yet on today, 5/12/16.
Pt received 4 month vaccinations - including Rotavirus and patient had watery diarrhea and leukocytosis up to 32.3. Pt was hospitalized at hospital.
Spotting vaginal; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting vaginal) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Spotting vaginal). At the time of the report, VAGINAL HAEMORRHAGE (Spotting vaginal) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 contains no significant information
Splitting headache, waking up in the night multiple times, shivering in spite of having 4 blankets.
developed hives today 1/6 after receiving COVID shot on 1/3/2021. The hives are on arms and legs and are itchy. referred to PCP today . Treatment course is currently unknown..
Information has been received from a nurse practitioner (NP), concerning a 17 year old male patient. The patient had no pertinent medical history and no known drug allergies. On 23-AUG-2012, the patient was vaccinated intramuscularly with one single dose of GARDASIL (dose and frequency were not reported) (lot #: 1537AA, expiration date not reported). There were no concomitant medications. On 24-AUG-2012, after receiving his first dose of GARDASIL, the patient developed urticaria or hives on extremities and on the trunk. The patient went to the E.R. to seek medical attention and was released. BENADRYL was given as treatment for the event. No lab diagnostic studies were performed. At the time of the report, in 2012, the patient had recovered from the urticaria or hives. The relatedness for urticaria or hives and therapy with GARDASIL was unknown. Additional information has been requested.
w/in 5-7 minutes p/vax pt slowly slumped to knees then fell to floor striking head on carpeted floor lightly; tonic muscle contraction of leg; pt cried c/o head hurting;
Patient developed fatigue the day after receiving her 2nd HPV vaccine (no problems after the 1st/dose). I saw her on 11/2/11 - normal exam/normal neuro exam. I explained HPV not likely a problem but mom wanted it reported. We discussed other possible causes of fatigue.
Within a minute of receiving the vaccine, I became lightheaded/dizzy/sweaty and almost fainted.  I needed an icepack, fluids, and to put my feet up.  This lasted 30 minutes, and then severe body aches, chills, fever, fatigue, cough, stuffy nose, dizzyness, nausea persist more than 24 hours later
Sore arm, and then later in the day, mild fever (101 w/Advil), chills, fatigue
Stomach cramp; A spontaneous report was received from a consumer concerning an 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach cramp.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately two days prior to the onset of the event, the patient received their dose of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced stomach cramp. It was not quiet bad and getting better. Treatment for the event  included paracetamol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event stomach cramp was recovering (getting better).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Not received 2nd dose yet; Face got red scaly chapped; Hives on my chest; Skin peeling on face; Itchy; Rash on face; Dead arm the next day; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day) and SKIN EXFOLIATION (Skin peeling on face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day). On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face). On 03-Feb-2021, the patient experienced ERYTHEMA (Face got red scaly chapped) and URTICARIA (Hives on my chest). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet). On 26-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day), SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient was prescribed oral steroids in response to events.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-May-2021 had new events to be updated
her arm was a little sore; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Apr2021 10:30 (Lot number: EW0161) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot Number: ER8734, 1st dose, Time: 10:30 am, Route of administration: Intramuscular), administration date: 02Apr2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "her arm was a little sore"; HEADACHE (non-serious), outcome "recovering", described as "Headache". Therapeutic measures were taken as a result of headache. Additional information: The patient states for the 2nd dose her arm was a little sore that day and that was it and she was going to check not serious on the letter and then 4 hours later after the vaccine is when the event occurred and her appointment was at 10:30am in the afternoon sometime.  No follow-up attempts are possible. No further information is expected.
Pt was administered an expired vaccine. Immunizations director as well as pt was notified. Pt was briefed on adverse events/SEs to look for that would need to be reported to us or to the ER. Pt verbalized understanding. Pt had no questions or concerns.
I was very weak and fatigued for one day. At the injection site, my arm was sore but I iced it and it went away the same day. Other than that, no other symptoms.
patient received an expired dose of ACT-HIB with no reported adverse event; Initial information was received on 23-May-2022 regarding an unsolicited valid non-serious case from a pharmacist via call center.  This case involves a 15 months old male patient who received an expired dose of act-hib with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 23-May-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine once (batch/lot number: UJ661AAA, expiration date: 06-May-2022, strength: standard) via intramuscular route in the thigh nos for immunization (formulation: unknown).  On 23-May-2022, it was reported that the patient received an expired dose of act-hib with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event (expired product administered).   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 the guidelines. 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.
103 fever, chills, aching, vomiting, headache, weak. For two days. Could not get out of bed except to bathroom
he had taken a COVID 19 test which was positive.   Symptoms included shakiness, chills, cough (present for months due to postnasal drip), lightheadedness, shortness of breath and weakness
1) Cellulitis around vaccinia site, treated and resolved with Z-Pack. 2) Concurrent molluscum contagiosum conformed by dermatologist.
itching in the arm that was injected, itching belly. some chills and shortness of breath x 1 week.
Right arm continues to hurt from shot.  Arm is hard to rise and it feel heavy.    More painful at night then daytime.  I have taken tylenol for pain, rub alchol and ice pack.  Which it has improve a little.
16 year old adolescent received the Moderna vaccine by mistake; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  It was reported that patient experienced no adverse events as a result of Moderna vaccine administration.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received, added second dose information and facility type information added.
Pt went to lobby told mom felt sick, threw up got very pale nurse brought back into clinic. Placed in lab chair that could lie back got VS 105/69 Pulse 60. Cold compress monitored, rev VS 108/72 pulse 62 continued to monitor BP 108/72 pulse 68. Stated felt better raised in increments. Pt able to stand and leave stating felt much better 8/21/17 12:40.
Parent called HD and reported that son has a redden area that is swollen on the back of his arm. It is warm to touch and he has a fever ( but doesn't have a thermometer to take it). RN told parent to give Tylenol for fever, use Benadryl by mouth and Caladryl to area and cool compress.
This spontaneous report as received from a physician via Pfizer regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, lot#, expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to vaccine. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).
I developed a 3" by 4" red, itchy, warm to touch rash, at vaccination site, with a mild headache and flu like symptoms. I called the pharmacy, and they recommended Benadryl, which I have been taking since then. As of today, my left inner arm still itch.
Approximately 5 minutes after receiving the injection a warm/hot tingling sensation began in my body rising up from my chest to my head. My throat and chest became tight. My heart began to race. It was difficult to breath. I motioned for help. A physician on site came over. Emergency services was called. An EKG was done in the rescue. It was normal.  Most of the symptoms resolved approximately 20 minutes later. I did not go to the hospital.  I left feeling not completely right with some discomfort in my chest.  One week later my right arm at the injection site became hot and red 4 inches by 3 inches by 4 inches around and the soreness returned.  It is still slightly pink with soreness.
Bad adverse reaction; Administered Shingrix SQ instead of IM; This case was reported by a nurse via sales rep and described the occurrence of adverse drug reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse drug reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The patient was administered Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient experienced bad adverse reactions after receiving Shingrix. It was unknown if the reporter agreed to follow up from GSK. The batch number for Shingrix was updated from NE3TD to NE3TG as per the sales data sheet.
Left acute brachial plexus neuritis, evaluated by neurologist.   12/14/06 Received medical records from neurologist which reveal patient eval showed decreased strength & grip in left arm/hand.  Tx w/steroids & pain meds & scheduled for EMG on 12/4.  No EMG report included.  T/C to neuro office to request EMG report.
been sick since got the vaccine shot on Friday the 14. very bad headache. back ache. nausea. runny/stuffy nose. dry, irritated throat.
Week 1: Headache, switching arm (left), high temp, uncontrollable shaking, fatigue, loss of motivation, nausea.
Itching sensation (i.e. 'hives') in upper and lower extremities.
Breakthrough case admission after two vaccines Pfizer 3/24/21 Lot# ER8733;  Pfizer 4/14/21 Lot# EW0164
Vaccine was given 09:30 and early next morning, 01:00, had low grade fever, aches, and chills. Theses symptoms lasted for about 16 hours and then improved quickly. By 6 pm day after vaccine, felt close to normal.