chrisvoncsefalvay/vaers-outcomes huggingface dataset:
61 year old patient was administered Fluzone HD by mistake/no AE; 61 year old patient was administered Fluzone HD by mistake/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional in.  This case involves a 61 year old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [lot number and expiry date not reported] via an unknown route at an unknown administration site, on an unknown date by mistake, for prophylactic vaccination (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of overdose and actual medication error due to Inappropriate age at vaccine administration.(Latency: at the same time of vaccination)  At the time of reporting, patient had not experienced adverse event.  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.  There will be no information available on the batch number for this case.
a 2 month old patient received the product FLUZONE QIV NP with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who received the product fluzone qiv np (INFLUENZA QUADRIVAL A-B VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 26-Oct-2022, at 11 am, the patient received a first dose of 0.5ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7741JA, expiration date: 30-Jun-2023, via intramuscular route in the left thigh as Immunization.  On 26-OCT-2022, at 11 am, a 2 month old patient received the product fluzone qiv np with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient used the product for the first time and was not using the product now.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event   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 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.
extreme fatigue, muscles/joint pain, h/a, gastrointestinal upset, constipation, diarrhea, chills-feeling cold, dry cough, fever;22OCT97 exp extreme diff breathing & dizziness;pt felt had the flu;. All these symptoms started on Oct 6, 1997 when the influenza, pneumococcal vaccines were administered. Her health continued to deteriorate and on Oct 22, 1997 in the evening she experienced extreme difficulty breathing and then later dizziness. At this point she was taken to the Emergency room of hospital. Felt nauseated at home- threw up at hospital. Asthenia, headache, diarrhea, no dyspnea, myalgia, dyspepsia, chills fever, flu symd, arthralgia, constipation, cough inc, reaction aggrav.
Sore, swollen and inflamed upper arm. I received the shot on 10/16/18, on 10/18/18 left arm (deltoid) was swollen and inflamed. Dr. put me on CEFLEXON.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 25 year old female patient. The patient did not have concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On approximately 22-NOV-2017 (reported as approximately one month ago), the patient was vaccinated with the first dose of GARDASIL 9, for prevention of diseases caused by Human Papillomavirus (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient became pregnant with last menstrual period (LMP) of 25-NOV-2017 and Estimated Date of Delivery (EDD) of 01-SEP-2018. Subsequently, on 22-DEC-2017, the patient received the second dose of GARDASIL 9, lot # N023952 with expiration date of 12-JUL-2020 (expiration date also reported as 17-NOV-2019), intramuscularly, for prevention of diseases caused by human papillomavirus, (dose was not reported). On the same date after receiving the second dose of GARDASIL 9, she was administered an unspecified type of pregnancy test in physician office which showed that the patient was pregnant; however, it was also reported that no laboratory tests were performed. That day was initial exposure to GARDASIL 9 was at 4 week(s). Due to the events, the patient went to a physician appointment. No treatment was given for the adverse events. No adverse effects were reported. No product quality complaint was involved.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022 at 11:47 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Feb-2022 at 11:47 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient received vaccine past its 30 day. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medication was reported by reporter.   This case was linked to MOD22-011-6773, MOD-2022-542869 (Patient Link).
Pain in joint involving hand/Pain in Knuckles; Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.). On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles). At the time of the report, ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.) outcome was unknown.      No treatment medication details were provided.   Dosage form for HUMIRA was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event Arthralgia was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trail.  Primary reporter contact for lot number information was unsuccessful.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620881 (Patient Link).
muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was resolved with sequelae.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine about 2 and half months ago from reporting date and developed muscle pain about 12 hours after that dose. The muscle pain lasted for a day and a half  and then resolved. The reporter did not consent to follow up. This case was 1 of 3 cases reported by the same reporter.
Patient developed itchy, urticarial rash over chest, back and anterior neck.  At the ER patient was given Dexamethasone 4 mg po x 1 and Benadryl 25 mg po x 1.  He was also given additional doses to be taken at home.
Per Patient report:  Headache started within 1 hour of vaccination.  the following day, Blood sugar and Blood Pressure rose to dangerous levels.  Nausea and vomiting.  Blood pressure 2??/185, Blood sugar so high unreadable >600?; Unresponsive, breathing labored O2 Stat was low and on oxygen, went by EMS to Medical Center. At ER Blood pressure and HR decreased to dangerous levels for approximately 6 hours. Patient stayed in the hospital for 7 days while he was monitored for continued changes in blood sugar and blood pressure as well as severe nausea and vomiting.
Inappropriate schedule of vaccine/ not received her second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ not received her second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The reporter was the patient. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Right arm sore and feel rotten all over.  Evening of 10/19/06 arm really hurting.  "Feels better today; but thought you ought to know about it.  "Applied heat to it" Client applied heat to it.  Took tylenol.
I was diagnosed with carpal tunnel syndrome on 12/31/2021. They wanted me to try sulfa salinize but I had side effects from that drug and discontinued use after 90 days. Both of my hands fall asleep during the day at night. It's very painful and tingly. I was dropping things and have weakness in my hands. My hands go numb when I drive or even when I'm not doing anything. They put me on methotrexate 30 days ago. It has been helping so far but I won't know the full effects until 90 days of taking the medication.
p/vax pt exp red, swollen arm w/hard brown spot at inj site; pain in rib; difficult to deep breathe; 5/7 pt condition resolved
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I woke up this morning with a rash starting at the bottom of my neck, breasts, underarms, mid-stomach, sides and lower back. There's pink splotches and reddish pink speckles/ small dots. It's somewhat itchy.   It it totally separate from the poison oak/ivy rash. (Looks completely different/ and way more widespread)
Patient woke up the next morning (3-14-19) feeling dizzy and had a headache. I kept her home from school. She seemed to do better as the day progressed. Before going to bed, she had a low grade fever (100-101) and was feeling really icky so I gave her some Ibuprofen. She slept until 3 am. She woke me up. She went to the bathroom and washed her hands. She felt warm to me so I put the thermometer under her arm-it was up, all of a sudden she stared straight ahead and said, "Mom, I can't see anything" and went blank. I called my husband in to help. He held her up.  We tried to get her to talk to us but she was unresponsive and her legs had also gotten weak. It lasted under a minute. I poured a little water in her mouth and wet a wash cloth and quickly put it on her cheek. She came back to and was able to walk to the couch and talked to us like everything was just fine. I gave her some Ibuprofen right away. I talked to a nurse in the morning (since this had happened to my son less than a day ago, and he was fine, I figured she would be ok too). A Physician Assistant saw her Friday (3-15-19) around 10:30 am and also had a strep test done to rule that out as a possibility. Patient has been having high fevers since going to the doctor's office until today (Sunday morning-3-17-19). Her highest fever was 3-16-19 at 6:45 pm -it was 103.7 (with the point added since it's under the arm). Even though she's had high fevers, she did not blank out or have a seizure (whatever it might be called) again. The high fevers were even after giving her Ibuprofen or TYLENOL. She was completely healthy prior to the flu shot.
insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (insomnia). At the time of the report, INSOMNIA (insomnia) outcome was unknown.            No concomitant medication information was provided by the reporter.  The patient took several medications for insomnia but nothing seems to work.
All of the standard symtoms notice when i woke in the morning and ptogressed throughout the day. Extreme severe heartburn for 4 hours after lunch, and again at night after icecream. Took two zantac in the afternoon and one pantoprazole at night. Still sever heratburn plus everything else...102 fever, chills, nausea, muscle pain, headache, tireness, inejction site soreness,  and sore throat
One day after vaccination child's left arm became very swollen and red from just above elbow to shoulder.  No complaints of pain, just directly at injection site.  Child taken to MD and instructed to put cold compress on skin was very hot to touch.  Resolved about 3 days later.
Within 5 minutes of receiving the shot, I felt as if I had a band around my arm with a very weird sensation, this lasted hours.  I had redness, swelling and pain for days afterwards.  Before the second vaccine on 6/25/2021 at a different pharmacy, I explained what had happened to the pharmacist and she made a comment "It must of been a rare side effect".  I should state that the first shot actually hurt when it was administered.  I had pain and redness and swelling that lasted for days following the second shot as well.  My arm has been getting increasingly painful and hard to lift as the days have gone by.  I have very little range of motion and sleepless nights because of pain.  I almost went to the ER because of this pain and loss of motion and will be calling my doctor in the morning for an appointment.  I tried to do the right thing by guarding myself against the shingles, however, now I am in pain 24/7 and can't lift my arm.  The pain is around the injection site and travels upward.
No symptoms prior-fell face first after stood up from chair and cut lip. Occurred 10 minute after vaccine admin. EMS attended patient. BP 120/80. Transport for lip sutures and evaluation. No other sx noted.
Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.). At the time of the report, OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient got a Moderna vaccine on 29Jul2021, later mentioned already had a Janssen vaccine one month before or so. The patient was monitored after getting the Moderna vaccine and presented no side effects. The patient had started a detox program 3 weeks before and was not receiving any medication at the time of the injection.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up information included no new information.
Trumenba vaccine was not due to be given. The doctor talked with the parent of the patient after checking the Trumenba profile and assured her that only normal side effects may develop.
Main symptoms are heart palpitations mostly occuring in early morning hours 2 am to 5 am, shortness of breath, swollen upper abdomen, pressure in chest, pain on left chest, neck and left arm, tiredness, and insomnia.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient had a sever form of vasovagal syncopy with fainting
Giant Cell Arteritis onset, diagnosed correctly in March 2023. By that time I had received every vaccine recommended by CDC for vulnerable elderly adults (5). My last dose was Sept 2022 prior to onset of GCA symptoms. Result was occlusion of temporal arteries effecting the left retina and right optic nerve. The left eye is now permanently damaged retinal area involving central focus. Confirmation by surgical biopsy and angiograms of arterioles of both eyes.
Tingling in the lips, received 50 mg of diphenhydramine, s/s continued transferred to ED.  ED EKG done, and normal rhythm, IV Pepcid 20mg given, with 1L 0.9% Normal Saline.  Patient discharged home.