chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a sales representative and described the occurrence of pertussis in a 4-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), DAPTACEL (non-gsk). A physician or other health care professional has not verified this report. Concurrent vaccination included influenza virus vaccine (Sanofi) given on an unspecified date. There were no concurrent medications. On 13 December 2007, 2 October 2007 and 27 July 2007 the subject received 3rd dose, 2nd dose and 1st dose of PEDIARIX. On 21 October 2008 the subject received unspecified dose of DAPTACEL (4th dose in the childhood series). At an unspecified time after vaccination with DAPTACEL and PEDIARIX, the subject developed pertussis (it was noted that the office learned of the pertussis diagnosis on 05 June 2011). This was considered to be vaccination failure. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the outcome of the events was unspecified. The subject did not receive his 5th dose in the series because he was under age before he acquired pertussis.
I got the shot; won't get them as bad/a spot the size of my palm on my back; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot) (serious criteria GSK medically significant) and shingles (Verbatim: won't get them as bad/a spot the size of my palm on my back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter said that the shot did not prevent you from getting shingles but if you do get shingles, you would not get them as bad.  The patient got the shot and year later got a spot the size of his/her palm on his/her back. The patient's son did not got shot but had shingles over most of his torso. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I got the 2nd vaccine on 4/09/2021.  Than I woke up the next morning and arm was sore, through out the day arm became itchy, red swollen, blisters, hot to the touch and very sore. This was around 1pm on 4/10/2021.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Pt started complaing that he feels tired right after vaccine dose administration, then started vomiting and complained that he is lightheaded, paramedics were called, the patient felt cold and kept complaing that he is very tired
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to cases 2018SA297838 and 2018SA297839 (same reporter). This case involves a four-years old female patient who was inadvertently administered 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ030AB and expiration date: 05-May-2019) via intramuscularly in the right thigh on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose because the vaccine was inadvertently given to a 4 year old patient. It was unknown if any adverse event occurred or not following the administration of the vaccination. 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.
2ml of normal saline was used to reconstitute the vaccine instead of the recommended 1.8ml.
,arm soreness the 2nd day. After a week had vertigo, tinnitus, lack of energy,about a 50% hearing loss and some chills.  Meclizine, saline solution. Symptoms are still present.
Vaccinated in Feb and got Covid recently; Vaccinated in Feb and got Covid recently; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Feb2021 as dose 2, single; dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced vaccinated in feb and got covid recently in 2021. Patient stated, he is feeling better. He wanted to know that do we have a Covid booster trial can he participate in. The patient underwent lab tests and procedures which included sars-cov-2 test was got covid recently in 2021. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had severe nausea and vomiting right when I got the vaccine and for four days afterwards. Shortly afterwards I had the absolute worst joint and muscle pain there is and that lasted two weeks until it was time to get my second vaccine which I did not even want to get. I contacted my DR the same day of the vaccine because I needed Zofran and then I contacted again 4-5 days later to talk about the second shot and they convinced me to still get it.
patient complained of feeling sick, not eating, drinking, walking after 1.5 days. had all covid symptoms. day six wife had to force him to eat baby food. took him to hospital where they tested him and said he was covid negative and that he was allergic to shot. said they didnt have anything they could do for him  since it was so rare and sent him home with extra fluids. on 9-21 or 9-22 he returned to hospital saying he had leaking fluids and black coloring on his foot. hospital told him he had necrotizing fascitis  on foot and removed leg below the knee to save his life.
pt recv vax & devel tenderness & swelling in the rt shoulder & axilla which was treated w/pred & DPH;
Approximately 8 hours after this dose I experienced  difficulty processing thoughts and completing basic tasks. The next morning I felt a bit clearer but not functioning at my normal cognitive level. Over the next 7 days I found myself doubting my ability to safely navigate in my car and avoiding normal speeds in traffic because I was fearful that my reaction time was insufficient.  I have experienced increasing difficulty remembering things that I have been performing in my work for 11 years. I find myself incapable of finding the word to express my thoughts. It has now been nearly 5 months and  I am continuing to experience these symptoms and actually feel the frequently and severity to be increasing.
This spontaneous report as received from a pharmacy technician concerning a currently 58 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 26AUG97 & approx 15min p/vax pt fainted for a minute;pt recovered;
49-year-old male who presented to the emergency department from Hospital for "respiratory distress." Patient tested positive for COVID-19 on January 13, 2022. When EMS arrived at Hospital the patient was satting at 97% and tachypneic. Patient has arrived to the intensive care unit at where he is on ventilator support via tracheostomy, 40% FiO2 and 5 of PEEP without respiratory distress.
This spontaneous report as received from a physician refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 25-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
At 12 month, began losing 3 work vocabulary. At 12-24 months, increasing gastrointestinal problems. At 27 months, dx'd with Autism. At 33 months +; clinical trials; fat soluble, vitamin A, later, followed by bethanechol, supplements, chelation. The 60 day follow-up states that the pt has autism; multiple mental totoxicity especially mercury. The pt's partent states that the pt was poisoned by thimerosal HB and was disabled by the pertusis vaccine.
This spontaneous report was received from an approximately 86 year old female patient with no pertinent medical history and no drug reactions or allergies regarding herself to report how she was feeling. On 25-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included vitamins (unspecified) and calcium (unspecified). Approximately on 01-JUN-2012 (reported as a week after vaccination), the patient started to feel numbness that went down to legs and feet. The patient sought an unspecified medical attention. She was told to take B12. On an unknown date, nerve test on legs and magnetic resonance imaging (MRI) were performed. The outcome of the event was reported as not resolved as this feeling had not gone away since the vaccination. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
This spontaneous report was received from a physician assistant concerning a 39 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. The patient's concomitant medications included an unspecified "antiretroviral". On 06-APR-2018, a HIV positive patient was vaccinated with a dose of PNEUMOVAX 23 lot # N029303 (expiry date: 21-APR-2019), subcutaneous in the left upper arm. "HIV positive patient" was also reported as a indication of the PNEUMOVAX 23. The physician assistant reported that on 07-APR-2018, the patient developed "a reaction" described as a "cellulitis infection that went systemic". On an unknown date in April 2018, CD4 lab test was performed. The patient's lab result on "above 1000 (units not provided)". In addition, the physician assistant reported that the patient sought medical attention in the physician's office on 09-APR-2018 and 12-APR-2018, in which the patient was prescribed and given KEFLEX and BACTRIM antibiotics as a treatment of the adverse event. At the time of the reporting, the patient's outcome was reported as not recovered. The reporter considered the adverse event as a significant disability or incapacity. Upon internal review, Cellulitis was considered to be an important medical event.
Systemic: Fainting/Unresponsive-Medium. Additional Details: Patient fainted about 5 minutes after receiving 2nd dose of vaccine. Pt hit his head on a table on way down. EMS called. PT was alert and oriented, but was taken to the hospital for evaluation by ambulance.
Received three vaccines.  Left Arm - HPV #2 and Right Arm - Fluzone and Hepatitis A.  Immediately after receiving vaccines, patient c/o feeling faint, nauseated and weakness in the legs.  Patient remained coherrent and blood pressures remained stable.  After 15 minutes, patient was released c/o of very mild weakness but reports that it was improving as she stood longer in one place.
12 hours after fits vac red blood blister on nose; flattened next day but came back at about 36 hrs.  Chest rash 36 hours after vac and last through night. 12 hrs after 2nd vac stomach upset and lose bowels; 2nd, 3rd and 4th day much fatigue sleeping 14 hours out of 24 hrs; went away after 4th day.
develop a fever today; bruised at the injection site; that it could possibly be Covid 19; coughing a lot / "those symptoms" and she said that she was coughing a lot; This case was reported by a consumer via call center representative and described the occurrence of cough aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu vaccine (fir Flu vaccine refer case US2020170274 and US2020AMR170986). Concurrent medical conditions included meat allergy (unspecified long list of medication) and lung disease.   On 21st August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced cough aggravated, injection site bruising and suspected covid-19. On 24th August 2020, the patient experienced fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the cough aggravated, fever, injection site bruising and suspected covid-19 were unknown.   It was unknown if the reporter considered the cough aggravated, fever, injection site bruising and suspected covid-19 to be related to Shingrix.  Additional details were reported as follows: The patient had a long list of medications that she was allergic to.  The patient had a pre-existing lung disease and that when she gets the flu shot she becomes ill because the flu shot is made with a chicken protein.  She has since recovered from all of these events but she states she was not going to get a flu shot again. She does not know the name of the flu shots she received but said we could contact her doctor for that information. The patient received Shingrix and asked had any chicken or fowl protein in it.  The Shingrix received via intramuscularly in the right deltoid and the last few days she had been feeling those symptoms again [and that she has been doing everything she can to ward it off (such as exercise). Those symptoms meant by was coughing a lot.  She said normally she does have a cough (due to her pre-existing lung disease) but this cough that she has been having has been intense.  She also stated that she was concerned that it could possibly be Covid 19 because one never knows and there have been cases reported in her state.  She said she wears a mask when she goes out. She also reports that normally her body temperature was in the high 97 to low 98 range but she did develop a fever of about 100 degrees. She did take ibuprofen and that got it down to 98.8 degrees.  She also mentioned that she was bruised at the injection site.  The reporter consented to follow up. This case has been linked with case US2020170274 and US2020AMR170986 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR170986:same patient (Shingrix vaccine) US-GLAXOSMITHKLINE-US2020170274:same patient
sleepy; sore arm; fever; fatigue; 1 mL was administered to four patients; This spontaneous case was reported by a medical assistant and describes the occurrence of ACCIDENTAL OVERDOSE (1 mL was administered to four patients), SOMNOLENCE (sleepy), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (1 mL was administered to four patients). On 22-May-2021, the patient experienced SOMNOLENCE (sleepy), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). 22-May-2021, the patient experienced PYREXIA (fever). On 24-May-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 25-May-2021, SOMNOLENCE (sleepy), PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (1 mL was administered to four patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Reporter information, patient demographics and additional events were provided.
Itch on upper arm of injection started on Feb 9, 2021.  Rash appeared around Feb  12, 2021 on upper arm. Rash is still in there with an old enlarging circle on the upper arm.
The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very tired. I began to have huge amounts of blood mucus, spitting it up and choking on it.  Was given a sinus infection amoxicillin antibiotic and musilix and nasal sprays. 2 weeks The heavy blood mucus traveled into my eustachian tubes, imparing my hearing and making me off balance...3 weeks. Experienced sever headahce for a week and went to ER for Ct scan . No stroke or anyerism .  Then the heavy bloody mucus went into my bronchi and lungs causing shortness of breath and weakness...given a pneumonia antiibiotic .  I am currently on a prescription for Prednisone ( on the refill) and improving slightly but still weak and tired and shortness of breath. Still having shortness of breath (6/26/21_ and very tired. Cannot perform all my daily functions like taking a walk .  I am able to prepare meals. adverse reaction still exits   2/25/21 - 6/26/21
A nurse reported that a male in his 30's, dx'd with HIV, received an injection of Pnu-Imune 23 in 10/00. Approx. 3 weeks later, the pt's anergy panel test-PPD/with candida and mumps results were negative. The reporter indicated that the pt should have a positive result because of "his good immune system".
she was told that 9 players and the coaches of the baseball team all came down with covid; she was told that 9 players and the coaches of the baseball team all came down with covid; This is a spontaneous report from Pfizer sponsored Program . A contactable consumer reported on behalf of multiple patients. This report was for player2 out of 9 players and coach.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller was told that 9 players and the coaches of the baseball team all came down with covid. The caller wanted to know why this has happened. The caller was asking whether the vaccine was not supposed to save you from getting covid. The outcome of the events was unknown.  Information about Lot/Batch number were requested
Patient hospitalized for 9 hours for stating that she started having contractions in the am that have progressed to 3-5 min apart on 7/11/2021. Patient hospitalized for active labor and delivery on 7/21/2021. These visits are within 6 weeks of receiving COVID vaccination.
BROKE OUT WITH CHICKEN POX 7 TO 10 DAYS AFTER RECIEVING VACCINE. FIRST SIGN IS SORES AT THE INJECTION SITE. SLIGHT FEVER, THEN MORE BUMPS ON FACE, SCALP, BACK AND NECK AREA. WAS SEEN BY THE DOCTOR AND WAS GIVEN (ACYCLOVIR) MEDICATION TO SHORTEN THE VIRUS.