chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a physician via a company representative, referring to a 15 year old female patient. There was no pertinent medical history. In "around September 2015" the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # was unknown) for prevention of HPV. In "around September 2015", the physician reported that the patient presented with a combination of "upper respiratory infection, strep throat and the worse hand, foot and mouth disease they have ever seen" after the dose of GARDASIL 9 injection. The patient was also been in and out of the emergency room (name and location unknown, date unspecified) and physician's office for a "variety of issues" including mycoplasma infection, mononucleosis and miscellaneous rashes. Unspecified antibiotics were given as treatment for adverse events. It was unknown if there was laboratory diagnostics performed. At the time of the report, the outcome of the adverse events was reported as "still sick". Additional information has been requested.
18month-old vaccinated w/MMR eighteen days after vaccination she developed a fever of 104 and macular rash of the face, torso & legs.  The symptoms remitted spontaneously, recurred 2 wks later described as vasculitis.  No further details.
Broke out with hives and redness at injection site, was given BENADRYL and over the counter ZANTAC, still has hives as of 1/15/19.
This spontaneous report was received from a certified medical assistant regarding multiple, unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with GARDASIL lot # K010215 expiration date- 05-MAY-2017 and lot # L018286, expiration date- 13-APR-2017 (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. It was reported that the Temperature: 54F, Time frame: 12 hours, Back in range- Yes, Previous temperature excursion- No and Was call because of a data logger- Yes. This is one of several reports received from the same reporter. Additional information has been requested.
DEVELOPED RED RASH (1" IN DIAMETER). PAIN AT INJECTION SITE. GAVE 25MG DIPHENHYDRAMINE AND MONITORED FOR 30 MINUTES AND THEN RESOLVED.
vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 months old female patient who experienced vaccines being given post temperature excursion (with no reported adverse event) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); HEPATITIS A VACCINE (HEPATITIS A); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 03-May-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7376NA(expiry date:30-Jun-2022)  via intramuscular route in the left thigh for Immunization.  On 03-MAY-2022 (latency: Same day) the patient developed a non-serious vaccines being given post temperature excursion (with no reported adverse event) (product storage error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccines being given post temperature excursion (with no reported adverse event)).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event vaccines being given post temperature excursion (with no reported 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 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.
Vaccine expired on 10/31/22, dose administered to patient on 11/3/22.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patient was vaccinated with one dose of improperly stored LIQUID PEDVAXHIB lot# N007749, expiration date 29-NOV-2019 or lot # N000238, expiration date 25-OCT-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 and 25 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA008878: US-009507513-1710USA008877: US-009507513-1710USA008876: US-009507513-1710USA008879: US-009507513-1710USA008875:
A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD).    Concomitant product use was not provided by the reporter.   No treatment information was provided.
05/16/2022 I did not have really bad symptoms, but felt a little bit of funniness in my lungs. I also had bad headaches, a little bit of a cough and runny nose. On 5/18/2022I I test positive with a home COVID test. I had a runny nose and my heart started beating crazy, 155 beats per minute. I called my cardiologist and called my PCP on the following day, 5/19/2022. My PCP put me on Paxlovid. I started taking Paxlovid on that day. My heart rate was at 150 beats per minute for around 30 hours, then it went back to normal.  I gradually started feeling better. The Paxlovid was hard on my stomach, and I had a chemical or metal taste.  On 5/25/2022, I tested negative for COVID. On 5/31/2022, I noticed I had a cough again.  I read that people on Paxlovid were having rebounds. I tested positive for COVID again that day. My symptoms were not as bad. I just had a cough and runny nose for about 3 days. I have now recovered.
received menveo  powder which was reconstituted with a sterile diluent; received menveo  powder which was reconstituted with a sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 10th August 2021, the patient received the 1st dose of Menveo. On 10th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provide are as follows: The age at vaccination was unknown. The patient received 1st dose of Menveo and powder was reconstituted with a sterile diluent other than the one provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
3/7/21 Some vision loss noted; 3/13/21 CT due to darkening vision loss to rule out stroke; 3/15 optic nerve images at Ophtamologist noted swelling. 3/16 optic nerve swelling diagnosed by angiogram with contrast, gradual vison loss (holes in visual field, loss of accuity, periodic darkening of visual field and weaking of colors noted. 3/19-3/20 MRI of head noted optic nerve swelling increased severity, no other neurological signs noted. Lumbar puncture to test spinal fluid, that was normal, fluid sent to healthcare facility for further testing of infection or auto-immune issues. Treated with IV steriods for 3 days course, 1 gram daily following out-patient steriod step down with Prednisone 60 mg day
On saturday morning, the day after vaccines, patient went outside to take her dog for a walk. Her arms were sore, so she swung them around 'windmill style. ' She said she then felt both her legs go numb and had to sit down. It lasted about 10 minutes. After 10 minutes, her legs felt better. She took it 'easy' the rest of the day and is ok now. She did not seek medical attention, but called to report to pharmacy and her primary doctor.
Approximate 2 inch local reaction. Area red, hot to touch, ithcy, bruised. Red bruised area traveling to top of forearm.
Pt vaccinated with Measles Monovalent/PPD developed itchy, teary eyes with swollen lids,Nasal Congestion; Painful nose; Dry cough; Increased Diastolic pressure & Increased PR.
On March 31,2021 noted red, raised, itchy circular patch at site of injection, 8 days previously.
Mother called to report that night he received the vaccine.  Hands felt shaky.  Nauseated the following day & has a headache everyday since receiving the vaccine.  No other known details re: headache.
Patient was vaccinated & waiting in waiting room. Patient's mom reports going to grab daughter who's eyes had rolled back & was shaking. Patient was conscious, alert, & responsive. Patient reported feeling clammy & dizzy & requested EMTs be called for evaluation. EMTs arrived within 5 minutes & evaluated patient. Vitals & heart were normal.
increased in blood pressure starting day 3 through 5 to  about systolic 139-142 over dystolic 83-90 from normally around 127/78.
Second dose after more than 35 days; same rash came back; Slept all day; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of receiving second dose after more than 35 days, Slept all day, Lethargic, and RASH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced SOMNOLENCE and Lethargic. On 04-Sep-2021, the patient experienced RASH. On an unknown date, the patient experienced receiving second dose after more than 35 days. On 03-Sep-2021, SOMNOLENCE and Lethargic had resolved. At the time of the report, second dose after more than 35 days and RASH had resolved.            Patient stated that she also felt wiped out. No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-310797 (Patient Link).
Soreness and redness at injection site. Headache began around 7 pm.  Awakened by chills about 1 a.m., put on warmer pjs.  Awoke about 7 a.m. , still with headache. Took one ibuprofen about 9 a.m.   Headache subsided within about an hour, didn't recur. As of 2nd day following injection (Monday, following Saturday injection), felt fine except for soreness and a red patch at injection site.  This was a far less troublesome reaction than I had with the first  Shingrix injection in February.
been sick ever since; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who had been sick ever since after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event been sick ever since (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (been sick ever since).  At time of reporting, the outcome was Unknown for the event been sick ever since.
Information has been received from a physician concerning an 18 week old female (also reported as 5 months old and also reported as 2 weeks after the patient was 4 months old) who was vaccinated with Rotateq. It was reported the vaccinations with Rotateq started when the patient was 2 months of age and that the patient received other vaccinations at 4 months of age. The physician reported that the patient received her second dose of Rotateq and within two weeks of getting it, she experienced "severe abdominal cramps and diarrhea". Onset date was reported as 2 weeks after the patient was 4 weeks old. The patient's mother took her straight to the emergency room where the patient was given a barium enema which did not work. The patient was diagnosed with intussusception which had to be surgically reduced. It was unknown if the patient was hospitalized. Subsequently (on an unspecified date), the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a physician (who is also the patient's mother) refers to a male patient of unknown age. No concurrent conditions or medical history were provided. The physician report that her son was administered the 3 doses in the GARDASIL series (strength, dose, route and site of administration, lot# and expiry date unspecified for all) on 26-JUN-2014, 10-OCT-2014, and 08-JAN-2015. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  1/26/2022 - Pt received Quadrivalent preservative free (Afluria) 0.5 ml IM today in Right Deltoid. 2/1/2022 - PT presented in the clinic to report following her flu vax on 01.26.22 she experienced adverse side effects, states she was in bed all weekend with diarrhea, fatigue, shortness of breath. 4/7/2022 Provider note: influenza vaccine allergy-patient reports on 2 occasions she had been made very sick by the flu vaccine the most recent reaction also cause her blood pressure to go up and her medications had to be adjusted she request that I put this in her record she has an allergy to the flu vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 09:30 (Lot number: EP7534) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "known allergies: fish protein" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 27Feb2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: HIV TEST POSITIVE (non-serious) with onset 25Aug2021, outcome "unknown", described as "I screened HIV positive and PCR negative. I had no HIV exposures, other illnesses, or vaccine except the Pfizer Covid vaccine"; HIV ANTIBODY (non-serious) with onset 25Aug2021, outcome "unknown", described as "It's possible the Covid vaccine Kick-started my vaccine-derived HIV antibody production". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of HIV test positive, HIV antibody. Additional information: Reporter was in a HIV vaccine study 2002-2006. It was a Merck vaccine that used an adenovirus vector with an HIV gag protein (I think). Due to the vaccine induced antibody, I would screen positive on some HIV screening tests, but always confirmed negative with PCR. About 4 years ago, I found out I no longer had detectable HIV antibodies so I began regularly donating   blood to the Red Cross. My last donation was 29Dec2020 and I did not screen HIV positive. I attempted to donate again on 25Aug2021, but I screened HIV positive and PCR negative. I had no HIV exposures, other illnesses, or vaccines except the Pfizer Covid vaccine between donations. I thought this might be of interest to your researchers. It's possible the Covid vaccine kick-started my vaccine derived HIV antibody production. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not receive any treatment before medical attention. Patient did not had Covid prior vaccination. patient was not tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Bruising throughout the arm of injection. The bruising did not appear for almost a week after the vaccinations
I had both vaccinations, old one and the new improved- still got shingles/ Suspected vaccination failure; I had both vaccinations, old one and the new improved- still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (old vaccine).   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 information was provided as follows: The age at vaccination was not reported. The patient had both vaccinations, old one and the new improved and still got shingles. The reporter had shingles but thought it was not as bad as it would have been if had not taken the vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Patient called clinic and reports on 10/4/21 since the day or 2 after receiving the second dose of Moderna COVID vaccine, he's been having  left sided jaw pain.  Pain 3-4/10, with out taking medications.  C/O pain when opening and closing mouth, and with eating.  C/o trouble touching the molars on his left side.  Denies issues with right.  Denies any facial movement changes, slurring speech, drooling, eye lid issues or any other complaints to face or throat area.
RECEIVED AN EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 32 year old male. 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: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. On 27-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received an expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931982, 20210932036, 20210931844, 20210931951, 20210932240, 20210932593, 20210932567, 20210932874, 20210933129 and 20210933076.
Pt brought back HPV cax from her pharmacy, HPV #1. Pt was waiting at the lobby after IUD insertion and HPV #1. FD initiated code blue. Pt fainted on her seat, her husband was next to her. 11:15 am Code blue called. RN and provider arrived at the lobby. Called pt's name but pt is not answering, eyes were closed. pt's husband reported, pt not responsive. VS: Bp 106/76, pulse 64, O2 sat 98 % on room air, BG 98, Hgb FS 11.5. Provider instructed to call 911 for EMS. 11:18am 911 called. Pt was escorted to floor by staffs. called pt's name and she was not answering and her eyes were reminded closed. 11:20am Vital Signs: BP 124/72, pulse 63, O2 sat 99% on room air. Dr. verbal order: IV fluids 5% Dextrose 0.45% Nacl 500ml. IV line was insterted by Dr. and IV fluids given, wide open. (needle gauge: 22, site: right antecubital vein). 11:25am Vital Signs: BP 120/80, pulse 68, O2 sat 100% on room air. Pt opened her eyes and she was responding to her name, where and when. 11:36am Called EMS again, they reported, it is on the way. Pt reported, she is A&O x3 and feeling cold and dizzy. 2 blankets given. 11:37 am 2nd bag of IV fluids given (0.9% Nacl). 11:40 am EMS arrived. Vital signs: pulse 68, O2 sat 100%. 11:50 am EMS and patient left the clinic. informed pt's husband that RN will call tomorrow for f/u and call back for any questions. He verbalized understanding.