chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received second dose for Twinrix today 9/11/2023, 3 months apart from the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 5th June 2023).   On 11-SEP-2023, the patient received the 2nd dose of Twinrix adult. On 11-SEP-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: received second dose for Twinrix today 9/11/2023, 3 months apart from the first dose).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-SEP-2022 The patient was self-reported this case. The patient reported that she received second dose of Twinrix adult vaccine 3 months apart from the first dose due to travelling out of the country. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since 02-NOV-2015, the patients were inadvertently administered with improperly stored doses of GARDASIL (lot# J010668, expiration date 29-APR-2016, lot# K007264, expiration date 02-MAR-2017, lot# K011325, expiration date 08-APR-2017, strength, dose and route unknown). No adverse effects had been reported. Additional information has been requested.
Admit for PNA, eventually tested positive for COVID-19 and DX with COVID-19 PNA, SBO and sepsis. Fully vaccinated. Steroids, cefepime. Exploratory lap 8/27. Patient was discharged to nursing home.
07/12/2008 presented to doctor office with hx 5 days of "Right arm aching/swelling". Diagnosis? Rt. axillary adenitis placed on KEFLEX 500 mg tid. No known Hx trauma. Has sensation to touch/heat/cold etc.; yet "tingly". Dx DVT and Paget Schroetter syndrome Aug 08. I called Mom this evening to discuss further her question regarding patient's Gardasil vaccine series and her n/o blood clot. Patient has had something called Paget Schroetter syndrome which is a subset of thoracic outlet syndrome. This is usually due to inadequate space for the subclavian vein to run through at the shoulder due to anatomic variations in the 1st rib and clavicle (thus causing blood clot) or can also be from anterior scalene hypertrophy from repetive UE use. Patient used to participate in karate so this possibly may have put her at risk for this. I also reviewed office visit notes. I also reviewed the time course of patients Gardasil vaccines. Her initial visit here for RUE swelling was 6-7 mos following her 3rd Gardasil vaccine. I researched Gardasil and blood clots over the weekend and most of the alleged cases of causality are in clots that occurred within days to weeks following Gardasil vaccine. I reviewed this w/Mom and advised that, given the cause of patient's clot being an anatomic etiology, and the fact that her Gardasil series was several months prior to her blood clot, I don't think the two are related. However I again emphasized that we may never know the true answer and I am only relating my observations based on my research into Paget Schroetter Syndrome and Gardasil/blood clots. Mom said she was relieved to hear this, I think she was experiencing alot of guilt for having patient complete the Gardasil series, in light of the complications patient has had from surgery for the aforementioned syndrome ( had a pneumothorax as a complication from surgery to remove part of a rib to make room for her R subclavian vessel). I also disc'd the VAERS reporting service and advised that we would submit patient info to them which may help eventually establish causality or otherwise down the road when they look at Gardasil. 12/1/2009 PCP and Specialist records from 7/2008 to 9/2009. Patient with c/o's sudden onset RUE swelling and pain. Tx'd initially with po ABX, Doppler + for DVT and placed on anticoagulant therapy. Patient had extensive surgery 6/2009, scalenectomy, brachial plexus neuroplasty, first rib resection and anteriolysis of subclavian artery. Patient had complication post op: pnemothorax. Dx'd with Paget Schroetter syndrome
This case was reported by a physician's assistant and described the occurrence of arthritis in an adult male pt who received Lyme disease vaccine recombinant (Lymerix). On an unspecified date, the pt received a dose of Lymerix (dose number not specified).  Several years after the pt received the Lymerix vaccine series, on an unspecified date in 2004, the pt developed arthritis and was seen at a physician's office. At the time of reporting, the event was unresolved. The physician's assistant considered the arthritis to possibly be related to vaccination with Lymerix.
pfizer vaccine temperature excursion. The vaccine was placed in the freezer for 3 weeks then removed and placed in the fridge for a week. After that the vaccine was adminstered,
Patient passed out after 5 seconds of injection. As per the patient's mother patient has a history of passing out couple of times while seeing blood or syringes. Emergency was involved and later after 2 hours  patient's mother came to the pharmacy and said she is back to normal and discharged from the ER
Pt. did not have reaction at injection site, but was very irritable after waking up from nap. He also had decreased appetite.
I got a cold after we docked from a cruise, and I tested on the 9th and the 13th, and they were both negative. I thought I just had a common cold, but my left leg started swelling on the 15th. I had something like varicose veins up my shin. When I got off the ship, I tested positive one the 22nd and was give PAXLOVID. The treatment did help the flu like symptoms, but I still have swelling in my lower leg. I went to my doctor, and they didn't think so but to be safe they are going to order some tests.
Around the time stated in form I began feeling slightly flushed in the face, general fatigue, as well as a slight headache.
Patient was here today for his 2nd Covid Vaccination in the series. Prior to the administration he shared that he felt very anxious today more so than his first vaccine. Both his mother and twin brother consoled him. Immediately upon administration of the vaccine, patient experienced what appeared to be a vasal vagal response. As the syringe was removed from his arm his arms and fingers became clenched , his eyes began to drift to the side and upward, he was very pale and diaphoretic. He was gently moved to the floor without incident. Immediately upon lying on the floor he became alert and oriented and his color began to return to his face and neck. Patient was able to converse. His vital signs remained stable BP 108/60, P 70's and oxygenation saturation remained 98-100%. He was brought to our recovery room and observed for 30 minutes without any other symptoms. Symptoms had fully resolved. He tolerated water prior to discharge..Upon discharge patient had remained stable, and both he and his mom felt they were ready to go home. His father met them here at clinic to provide support and comfort. Of note patient will be seen at his Pediatricians office on Monday for his annual visit.
Child was given the Hep B at birth.  Child was born healthy and  other had zero pain meds or delivery assistance from medication.  Natural healthy vaginal delivery.  After being administered the Hep B vaccine, baby began projectile vomiting with such force it appeared she would aspirate.  Child was immediately placed in the NICU for five days.  Child was chronically ill following this and has a neurodevelopmental delay, chronic ear infections, bowel issues and skin allergies.
Passed out in the restroom and broke nose at 3am 2 days after receiving second shot.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 09-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
COVID-19 Vaccine Clinic.Hospital  Staff member received 1st dose of COVID 19 vaccination and approx 15 minutes later c/o diaphoresis, palpitations, throat ""feeling thick/swelling"" and tingling in fingers. She was able to speak clearly, no increase in salivation, breathing calm. She was moved via wheelchair to the hallway for privacy. Vitals 123/77,  HR-76, RR 20. She was given sips of water. Staff observed her for 40 minutes and symptoms improved. Pharmacy was consulted and the staff member administered her own Claritin. She stayed for another 20 minutes without return of symptoms and was released. She was encouraged to contact her personal physician to discuss. She was also given the V-Safe information and encouraged to report her experience.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient had no known allergies. Pertinent medical history includes hypercholesterolemia and vasomotor rhinitis. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as H015749) (0.5 ml, intramuscular). Several days after receiving PNEUMOVAX23, on 02-MAR-2013 the patient experienced redness, tenderness and warmth at injection site. The patient notified unspecified primary physician and was prescribed antibiotic, cephalexin. Patient visited an Urgent Care Facility for medical attention on 07-MAR-2013. Reason for visit was unspecified. The patient was treated for unspecified reasons by a physician. Patient currently prescribed simvastatin. Pharmacist stated that the patient was fully recovered at the time of report. There was no laboratory diagnostics study performed. Action taken for PNEUMOVAX23 and causality were not provided. This is one of several reports received from the same source. Additional information is not expected.
The patient passed by three days after vaccination and was sent to the emergency room.  The patient felt dizzy and week during the time. and was trembling for 2-3 hours.
Pt was admitted to psych unit on 10/13 and developed fatigue, cough, body aches, congestion, and fever.  COVID swab was positive and he was moved to the medical/surgical COVID unit.
This spontaneous report as received from a pharmacist refers to a 65 years old patient of unknown gender. On 27-SEP-2013, the patient was vaccinated with 2 pediatric doses of RECOMBIVAX HB (lot number, expiry date, route and dose were not reported) to equal one adult dose. No adverse effects reported. This is one of the two reports received from the same reporter link (MARRS#1310USA013810). Additional information has been requested.
I/P C/O OF RUNNING NOSE, NASAL CONGESTION, DIZZINESS, SOB AND BURNING SENSATION. TREATMENT: EPINEPHRINE, SOLUMEDROL, BENADRYL, ALBUTEROL AND RANITIDINE AND SENT TO CODE 2.
Client received injectable influenza vaccination on 10/13/2015 in left deltoid.  The client tolerated the injection but reports over the next couple of days that she noticed increased soreness in the area and then began to experience a radiating pain.  The pain began in the proximal left upper extremity and radiated toward the shoulder.  Over the next few weeks, she notice occasional "zings" that radiated down her left arm.  She also began to experience weakness and increased pain with this occurring two weeks after the injection which is now subsiding.
Pt states around 9:00pm, her voice got hoarse, raspy sounding. No s/s of infection.
Patient is a 43-year-old male who is seen in consultation for Dr. for evaluation of left arm lesion. Patient had hepatitis A vaccination injection on 10/8/18. States at the site of injection in his left upper extremity, he noticed swelling and tenderness 3 weeks ago. Rates pain 2/10. Reports erythema and warmth to touch at the site of injection in his left upper extremity. Denies drainage, fever, sweats, chills. I&D Left arm. Wet-to-dry dressings BID. Cultures obtained.
pt had hyperpyrexia t106.5 w/sz; taken to ER; eval by MD;
On 01-12-2021, I began to feel dizzy, had  headaches and felt nauseated while at work. On the following morning, I felt nauseated and had diarrhea and while driving to work I continued to feel dizzy.  I went to work for a few hours only because I still felt nauseated, dizzy and continued with the diarrhea. This lasted three days. I missed work due to my diarrhea and how I was feeling. I saw a who prescribed nausea medication and anti-diarrhea medications. I also had a Covid-19 test which was negative.
Vaccine given outside of indication/no AE; Vaccine given outside of indication/no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was 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.  Documents held by sender: none.
On Wednesday I woke up with a fever staying over 100,  a cough a bad headache and bad chills.  The cough and fever and chills are still present on Thursday eve.
64 year old patient was given fluzone HD by mistake with no adverse event; 64 year old patient was given fluzone HD by mistake with no adverse event; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 64 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ235AB, expiry date: 04-Apr-2020), via intramuscular route in the left arm accidentally on 12-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.   It was reported that a 64 year old patient was given Fluzone HD by mistake.  At the time of reporting, the patient had no 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.
Disoriented, confused, dizzy and resulted in fainting and was unresponsive for 2 minutes
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better.  Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator.  Had presyncopal aura, then fainted.  Apparently fell on buttocks, which are sore.  No other symptoms.  Constitutional symptoms have resolved. Evaluated in ED today.
I have been experiencing random arm pains at my injection sites for months. It started gradually and I thought it would go away, but it has just gotten worse and became a sharp pain where sometimes I can't even move my arm. It gets worse after I use my arms more often but the pain will consist days after. It used to occur once a month, but now this happens around 3 times a week and it is only the exact area where my vaccine was administered and not my entire arm.
Headache, Sedation, Myalgia, Chills, arm pain and redness Received 1st dose on 12/31/20. On 1/1/21 noted extreme fatigue and myalgias. Received 2nd dose on 1/26/21. Awoke the next day with chills, headache, myalgias and fatigue. Symptoms lasted until that evening. Noted red, sore arm on 1/27/21 which lasted 48 hours. Missed work x1 day. No known prior COVID infection.
Developed Shingles (never had before) a month after getting vaccine. Not sure if related but thought I should report
pt recv vax 28OCT96 & devel influenza type A on 8JAN97 & was hosp;
Patient felt dizzy all day, said she "didn't feel well", then came down with fever in evening.  101.5 at bedtime.  Ibuprofen was effective.
Patient diagnosed with an otitis media 2 days after imms, was recovering but continued to have congestion and some antibiotic associated diarrhea. On 7/7 he had a generalized unprovoked seizure he was afebrile seizure lasted 90 seconds. He has now had 6 seizures between 7/7 and 7/10, started KEPPRA and phenobarbital. Spent 1 night in the hospital. EEG is.
headache about 2 hours after booster shot this occurred with the second shot as well  the headache was gone by the next morning
Suspected vaccination failure/both vaccinations and I'm on my 3rd episode of shingles; my 3rd episode of shingles since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that it was the same for him/her. The patient had both vaccinations and was on his/her 3rd episode of shingles since. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
was diagnosed with trigeminal neuralgia, have had issues with menstrual cycle, thyroid issues, basal body temp has increased to a constant low grade temp.
Headache, sinus pressure, dry lips, sneezing, lethargy, muscle pain
shingles type rash on right hip about 12" in diameter. same on the middle lower back. took about 7 days to start to go away, burning itching rashing
Checked BP, was 199/99, was going to call Dr. in AM, but starting having tingling in left cheek.  Went to ER, as my Mom died of stroke, where my BP registered 216/126.  After CT scan, MRI, leg dopplers, echocardiogram, and bubble test, all which were uneventful. I was kept for observation until Tuesday afternoon.  I was put on Plavix and Lipitor and released.  I don't know if this was just a coincidence, but figured I should report it just in case.  At the time of my vaccination, i had NO pain at the injection site, but a week later and since have had a slight pain at the site.
SLIGHT HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight headache, and tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight headache, and tired. This report was non-serious. This case, from the same reporter is linked to 20210843246.
Pt called and reported hearing loss that is permanent. She had the vaccine on 03-05-2020 and the hearing loss was on 07-27-2020. She states that she had seen an ENT that diagnosed her with this hearing loss. She believes it is caused by the vaccination.  Patient states that she seen a ENT, but she did not mention this problem to her. Patient called me on 09-15-2020 to report side effect.
administered an expired MENACTRA vaccine to a patient with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who got administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml (TOTAL) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Strength = Standard) Solution for injection (lot U7273BA) (expiration date- 24-Apr-2023) (expired product administered) (latency- same day)via unknown route in unknown administration site for Immunization.  Action taken- not applicable.  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.