chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
Recipient was fully vaccinated as of 02-16-2021 with 2 doses of Moderna. He came to the vaccination center on 08/23/2021 and received  1st dose Pfizer. He did not inform staff that he was previously vaccinated.  When contacted, the recipient stated he came for the Pfizer because he had 2 antibody tests several months after receiving the second Moderna  and both were negative. So he came for the Pfizer as a booster.
fever; sore; Fatigue; tested positive to have covid virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solu-tion for Injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 20Mar2021 as single dose for covid-19 immunization. Medical history included lymphoma from an unknown date and unknown if ongoing (a lymphoma survivor). The patients concomitant medications were not reported. On 01Apr2021 the patient tested positive to have covid virus. His wife got positive but not taken any of the doses yet. He also mentioned that he experienced fever, sore and fatigue on an unspecified date. The patient will get the 2nd dose on 12Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Arm began to ache at about 7 pm, 6 hrs. after administration. Pain progressively worsened to point, she felt like her rotator cuff tore. Inability to apply deodorant. PT appt. 10/28/14 who said possible impingement syndrome; taped shoulder. Pain keeps her up at night and rates 4 on 1 - 10 scale. Taking ibuprofen with minimal relief.
10:15 p.m. Mother noted he was running a fever she went to get the thermometer when she came back she said her child was shaky, unresponsive and was limp. She called the EMS. When EMS arrive child was moving his eyes spontaneously and took a toy appropriately from them. In the ER temp was 103.4 O2 98% P 166. Child did not look postictal no tonic-clonic activity. Given MOTRIN with good response watch for 1 hr temp down to 101 alert and interactive-discharged to home.
Had been vaccinated & still had shingles not as bad/ Suspected Vaccination failure; Had been vaccinated & still had shingles not as bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient had been vaccinated and still had shingles not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Resident noted unresponsive, unable to open eyes when repeatedly called; noted lethargy and unresponsive to stimulation. Upon assessment, no labor breathing noted and VS: BP 163/101 P 74 T 98.4 R 18 O2sat 99% FS 148mg/dL. Resident unable to open eyes independently/move his limbs.  In acute care - ddx includes seizure vs syncopal episode.
arm warm to touch at injection site, arm swollen, arm red from shoulder to just above elbow, stiff neck
RSF-28615-53273 Record in CDC V-Safe also records same details.  Starting 5/14, increasing pain from, site of injection, through elbow, and into forarm.  Significant dibilitating pain experienced when reaching, pointing, grasping, twisting forarm.  Sought care from WVU Urgent Care.  Weakness and grip strength noticeable compared to other arm.  No obvious signs of stroke  seem isolated to injection site and below.
Fever @ 101 degree Chills Abdominal Pain @ 2 days Injection site swelling and pain - on going as of 9/16/2021
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Started with severe headaches after the first covid 19 vaccine dose.  Also, she had a normal estrogen October 2020 and it came to undetectable on January therefore having a premature menopause due to the vaccine
Only time I ever got the flu was the year I got the shot; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a patient of an unknown age and gender who reported only time i ever got the flu was the year i got the shot after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, administration site, lot number and expiry date) for immunisation.  On an unknown date, the patient experienced only time he ever got the flu was the year he got the shot (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken: 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.
3 days after vaccine i lost all taste in my mouth and inflamed taste buds my tongue was swollen for about 4 months, i still have issues with my mouth  a week after vaccine i started having numbness and tremors in my left arm that is still on going. i have recently discovered that i have no digestive enzymes in my saliva and thinking that the reason is because of the mouth issues i had from the covid vaccine.
My Mom started mentioning on 5-23-22 that she wasn't able to poop, she thought that she was just backed up. This continued for the nest two weeks and on 6-6-22 she was going for her daily walk and felt tingling in her foot. Mom decided to return home and relaxed for the night. The next morning she had pain in her leg and butt area and decided to see a chiropractor. The pain continued to get worse for the next couple days. I brought my Mom to Urgent care on 6-10-22 because I was concerned about the amount of pain and loss of mobility that she was having.
12-month-old boy son. He received his MMR#1, Varicella, and HIB #3 vaccines on March 10, 2004 in the pediatric clinic. Within 20 minutes of receiving the immunizations, he reportedly developed facial swelling especially around the eyes, reddened skin, and hives over his entire body. His parents returned with him and he was taken into the treatment room. He was given Benadyl by mouth but vomited that. The Benadryl was repeated intramuscularly.  Mom reports that HE was getting over a cold on the day of his vaccinations. However, he was afebrile and asymptomatic. She does not believe that he exhibited any difficulty breathing during his reaction to the vaccinations. He did not require oxygen. Mom's major concern was the swelling around his eyes. He was subsequently discharged home to his parents after about 30 minutes. There has not been a repeat of the reaction. Mom reports that his twin brother did not have any reaction to his vaccinations.
Dizziness, Headache & Myalgia  Narrative:  Patient received 2nd dose of vaccine on 3/10/21 at 12:15pm and  began experiencing symptoms 3/11/21 around 1am. Reported symptoms include  chills, headache, body aches, tiredness. Only reported medication used for  symptoms was Tylenol (no dose/frequency reported).   Other Relevant History:
Developed symptoms of neuropathy with numbness and electrical shocks in the feet/toes within a few days of immunization, and this has progressively worsened and is still ongoing.  This sensation was also ultimately noticed in both arms, but that has since subsided.
Very mild low grade headache since first vaccine.  The intensity has not changed.  It is not intense enough to require OTC medication.  Just there under the surface enough to make me aware that it's there.  I am only reporting this so you know.  I will discuss at my next wellness visit with my primary care physician, but unless it gets worse, further treatment is not necessary in my opinion.
Information has been received from a consumer concerning his 21 year old daughter with TEGRETOL allergy who in May 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). Two months later, in approximately July 2007, the patient experienced her first seizure. On an unspecified date the patient was vaccinated with the second dose of GARDASIL (lot number not reported). Two months after the second dose the patient experienced another seizure. On an unspecified date the patient was vaccinated with the third dose of GARDASIL (lot number not reported). After the third dose, the patient still experienced seizures. It was reported that "at one point, she was taken to the emergency room because her roommates were worried about her" and "most recently the left side of her body has been locking up and contracting, and last night (20-SEP-2009) it spread to her right side". There were some office visits. Unspecified lab studies performed, and no result provided. At the time of the report, the patient not recovered. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
I got shingles after my second does of the Pfizer vaccine.  My second shot was on 4/13/21 and I woke up with shingles on 5/20/21.  I am 33 years old and in good health. I am now taking valacyclovir 1 GM and prednisone 10mg for the shingles.
This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a consumer and follow up information from a registered nurse  concerning her 4 year old son with a history of difficulty in breathing (present prior to administration of vaccines on 12/03/03) which had not been diagnosed and was noted to be possible allergic asthma and who received a first dose of MMRII on 12/14/00 which was well tolerated. On 12/03/03  at 10:30 am the pt was vaccinated subcutaneous in the right arm with a second  dose of MMRII (Lot # 645626/0396N). Concomitant therapy included albuterol nebulizer as needed and vaccination on 12/03/03  at 10:30 am witha fourth dose of poliovirus vaccine inactivated (IPOL) (Lot #W1619) given IM in the left arm and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot # DTPA616A2) given IM in the left arm. On the way home from the office, on 12/03/03, her son had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported she took her son back to the physician. The pt received a prednisone injection. Eventually he recovered from this event. Follow up information reported that immediately after vaccine, patient with a runny nose, nasal membranes edematous and upper eyelids edematous. The patient was given one and a half teaspoons of prednisolone (Prelone). The registered nurse reported this required a doctor visit and she also reported the patient recovered. Upon internal review severe allergic was determined to be an other important medical event (OMIC). No further information is available.
Severe chest pain (he said it hurt to breath) Fever for 2 days. He had acetaminophen every 4 hours.
This case was reported by a nurse and described the occurrence of drug dose administration too short in a 75-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). Concomitant products included ENGERIX B adult. On 21st January 2015, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received:
COVID ARM - RED CIRCULAR LESION AT INJECTION SITE WITH SLIGHT SWELLING AND ITCH - IS RESPONDING TO HOME TREATMENT OF COLD COMPRESSES AND IBUFROFEN
MMR administered 1-17-07. Brought in to office on 1-29-07 with red, diffuse slightly elevated, itchy rash and congestion x 3-4 days.
About 3-5 minutes after receiving HPV, patient became lightheaded, pale. with clammy hands and had tonic clonic movements for <1 minute.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient received Paxlovid as covid-19 treatment from 27Nov2022 to 29Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness, swelling, pain at injection site. Redness and swelling by early morning 5" X 2".
SHIVERING COLD WITH BODY; FELT FEVERISH; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced shivering cold with body, felt feverish, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt feverish, shivering cold with body and headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20230560836.
2x4 cm axillary mass- red and tender- suspect axillary abscess vs severe lymphadenopathy
15 -20 seconds after 1st of 4 shots, our child stopped breathing, turned blue, eyes rolled behind head and he went into full convulsions for over 2.5 minutes. It has only been 3 days since the seizure so we do not know the full outcome or ramifications yet.
Right arm pain and numbness,  shoulder, both back area  on right side and pain and chest heaviness. Shortness of breath. Pain when trying to take deep breath.  The shoulder, chest and back pain was unbearable for seven days
Took flu (seasonal) shot & had a reaction of red skin, itching, feeling hot - no swelling or constraints on breathing. (No site reaction).
Severe chills, difficulty breathing, vomiting, rapid heart beat, fainting  The same thing happened with flu vaccine in 2021
Information has been received from a nurse practitioner, concerning her friend's daughter, an adolescent female who was vaccinated (date and dose not specified) with a dose of Gardasil. Following the vaccination, the adolescent experienced a headache which lasted about 2 hours. No further information is expected.
PT RECD FIRST DOSE OF MODERNA 4/23/21 AS A MINOR. PT CAME BACK TODAY FOR SECOND DOSE. PARENT WAS EDUCATED AND INFOR PROVIDED REGARDING MODERNA FOR MINORS. CONSENT SIGNED. PT RECD SECOND DOSE TO LEFT ARM.
Mom reports rash started evening of 10/17/06 on left thigh but by am had spread across left thigh, wrists.  Swelling and erythema also present.  Diagnose per medical doctor allergic dermatitis status post vaccine Tri-diphenhydramine 125 3.75 ml by mouth every eight hours as needed, TYLENOL 8 ml by mouth every four hours as needed.
This spontaneous report as received from a physician via company representative refers to a female patient on an unknown age. Information regarding the patient's pertinent medical history and drug reaction/allergies was not reported. Concomitant therapies included ibuprofen. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiration date, dose and route of administration were not reported). On an unknown date, after vaccination with GARDASIL, the patient experienced severe fatigue, headache and malaise. It was reported that the symptoms lasted approximately 5 days, but the patient' status was unknown. There was no product quality complaint. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
pt died @ home; medical records from doctor who signed death certificate do not mention being positive for COVID, but there is a positive COVID test reported from Lab, test was submitted on 9/11/21; pt died on 9/18/21; COVID -19 is also listed on the death certificate; no other information found on this patient
Information has been received from a physician concerning an 11 year old male with a history of pertussis and no drug allergy who on 02-JUN-2009 was vaccinated with VARIVAX (Merck) (lot # 664018/0475Y) 0.5 mL, SQ. Concomitant therapy included ADACEL (unspecified) (+) tetanus toxoid and tuberculosis skin test. On 03-JUN-2009 the patient developed local injection site reaction. The patient had red, swollen, hot tender area that covered most of the upper arm. There was some "streaking" on the area. An antibiotic (not specified) was given to the patient. The patient had no lab diagnostics studies performed. The physician saw the patient. At the time of the report the patient was recovering. Follow-up information has been received from a physician concerning this 11 year old male student with amoxicillin and dairy allergies and a history of pertussis in the winter and peanut allergy (resolved) who on 02-JUN-2009 at approximately 04:40 PM was vaccinated  SQ with the second dose of VARIVAX (Merck) (lot # 664018/0475Y) in left the tricep. Concomitant vaccination on the same day at approximately 4:40 PM included the first IM dose of ADACEL (lot # C3058AA) in the left tricep. There was no illness at the time of vaccination. Subsequently, on 03-JUN-2009, the patient experienced flushed, nausea and edema and erythema of the left triceps. The patient also experienced worsening dizziness. Medical attention was sought, the patient was seen on 04-JUN-2009 and diagnosed with possible cellulitis. The patient did not have a fever. The patient was treated with KEFLEX for 7 days. At the time of the report, the patient recovered on an unknown day. No further information is available.
A couple of minutes after the vaccine I started feeling very dizzy,  nauseas. My husband had to drive me from the vaccine site back to work. When I got to my job they sent me to the ER because of how I was feeling. My heart rate was very fast, my blood pressure was very high they did blood work & my potassium came low. I got sent home & this symptoms lasted for about 3 days.
This spontaneous report was received from physician assistant (who was also the stepdaughter of the patient) via field representative regarding a male patient of unknown age. The patient's medical history included urinary blockage. The patient was immunocompromised. On an unknown date the patient was vaccinated with ZOSTAVAX lot details, dosage regimen and route unknown. Concomitant medications were not reported. On an unknown date the patient developed unilateral chest rash that was indicative of shingles outbreak and the patient also developed unspecified neurological side effect during unspecified time after receiving a dose of ZOSTAVAX. The patient sought medical attention and visited physician. No treatment was given for the events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been provided. Additional information has been requested.
Information has been received from a physician concerning unvaccinated 11 month old female twin who's family member was vaccinated with a dose of varicella virus vaccine live and subsequently developed a rash (WAES0506USA00565). In Apr 2005, the pt developed chickenpox. Unspecified medical attention was sought. At the time of the report, the pt was recovering. A product quality complaint was not involved. Additional information has been requested. The physician also reported a case a chickenpox in the pt's unvaccinated twin sister (WAES0506USA00501).