chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2005, when the patient was 12 years old, was vaccinated with first dose of GARDASIL (strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in 2017, reported as "last year", when the patient was 24 years old, was vaccinated with first dose of GARDASIL 9, as second dose of dose in the HPV vaccination series (strength, route of administration, anatomical location, lot number and expiration date were not reported).
Employee complained of feeling lightheaded. She reported blotchy spots on neck and chest; tingling to back of throat. Employee was taken to ED for further evaluation and treatment.
Patient indicated had sudden onset of fever, chills, vomiting and diarrhea for 2 days.  No medical treatment received and made full recovery.
yeast infection with her shoulder; left shoulder has arthritis; bursitis; Initial information regarding an unsolicited valid non-serious case was received from a Patient via agency (Reference number- 00354717) and transmitted to Sanofi on 11-Nov-2020.  This case involves a 74 year old female patient who experienced yeast infection with her shoulder (Fungal infection), left shoulder has arthritis (Arthritis) and bursitis while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  In October 2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE in her left arm and that the was injection was given, "at the highest point on her arm, close to the bone in her shoulder, (lot number: UJ236AA) via unknown route at an unknown administration site as prophylactic vaccination.    On an unknown date, she could not tell exactly where they gave the shot, but it was not like her previous shots. She recalled the staff who administered the injection was "on her 2nd day". The next day she could not move or lift her left arm, she stated she continues to have issues and it was still sore. She also experienced a yeast infection and said, " I thought my insides were coming out." Consumer reported she never had a yeast infection or issues with her shoulder before receiving the FLUZONE HIGH DOSE vaccine. Also reported that her doctor did not tell her it was a different shot than the ones she received in the past, or what the possible side effects are. X Rays were taken and her doctor said her left shoulder has arthritis and bursitis and one more condition the consumer could not recall. Consumer stated she will never get any kind of shot from this experience. She requested an anatomical shoulder image to be included in the letter. This way she can mark where the injection was given because she feels it was given too high.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for all events.
My husband was sick with cold symptoms. I had a scratchy throat and a slight headache, but I always have that, so I didn't think much of it. He was running a fever, so we went to the medical facility on the cruise ship. He tested positive for COVID-19. Since he tested positive, they tested me for COVID-19 as well. The result was also positive. After that, my symptoms got worse. I was very congested, tired, and had a bad sore throat. We quarantined in our cabin for five days. After five days, I was still a little congested and had a cough, but they released us from quarantine. The medical facility gave us cough syrup, Tylenol, and cough drops. We also took Benadryl. I still have a slight cough but most of the symptoms are gone. I retested myself for COVID-19 upon returning home. The result was negative.
Information has been received from a pharmacist concerning a 60 year old female who on 11-OCT-2010 (also reported as 14OCT2010) was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 664671/0149Z, expiration date 01-APR-2011) in the left arm. The pharmacist reported that one week after the customer received the vaccine she still had a "hardness" at the injection site, but no rash. The patient reported that she went to see her physician on 18-OCT-2010. The injection site reaction was 3 inches by 1 inch, red, warm and itchy. It began on 16-OCT-2010 (also reported as 17-OCT-2010). These events persisted. The healthcare professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination. Additional information has been requested.
The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient received booster dose. The vial did not undergo any temperature excursion. The vial was stored in refrigerator on 04-May-2022.   No treatment medications was reported.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical condition were reported. On unknown dates the patients were vaccinated with GARDASIL lot number not provided, dose, route and anatomical location were not reported, after an interruption of the recommended vaccination schedule for the vaccine. No adverse effect was reported. Additional information has been requested.
Information has been received from a health professional concerning a 24 year old female who on 05-FEB-2007 was vaccinated with Gardasil.  Concomitant therapy included DEPO-PROVERA.  On approximately 19-FEB-2007 the patient experienced blurry vision.  The patient's vision "was negative 600 and is now negative 700."  The nurse practitioner reported that Gardasil would not be reintroduced.  Additional information has been requested. This is in follow-up to reports previously submitted on 06/14/2007. Initial and follow-u information has been received from a health professional concerning a 24 year old female with a history of and no illness at the time of vaccination who on 05-FEB-2007 was vaccinated at 16:20 in the right arm with a first dose of GARDASIL (lot # 655619/1427F). Concomitant vaccinations included a fifth dose of DEPO-PROVERA (Lot # 06P601) in the left arm. On approximately 19-FEB-2007 the patient experienced blurry vision in the left eye even with contacts and glasses. The patient saw an eye doctor and her vision for the past two years was negative 600 and is now negative 700. The nurse practioner reported that GARDASIL would not be reintroduced. At the time of this report, the patient had not recovered. Additional information is not expected.
This spontaneous report was received from a health professional referring to an unknown number of patient of unknown age and gender. On an unspecified dates in March 2015 (reported as "between 19-MAR-2015 - 23-MAR-2015"), the patients were inadvertently vaccinated with improperly stored doses of GARDASIL (lot# K006960; expiration date 19-FEB-2017) dose and route of administration were not provided. No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of possible overdose in a female subject of unspecified age who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date the subject received a dose of HAVRIX adult (unknown details) and experienced possible overdose and possible inappropriate age at vaccine administration. It was unclear from the reporter what dose of HAVRIX the subject received. The exact date of administration of HAVRIX was not reported and it was unclear if the subject was 18 or 19 years old at the time of vaccination. Based on the lot number the subject was administered the HAVRIX adult. No further details were provided.
came down with COVID; came down with COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204), on 30Mar2021 as dose 2, single (Lot number: EW0150), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 22Apr2022 as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy induced asthma" (unspecified if ongoing), notes: Comments: Allergy induced asthma She has a history of allergy induced asthma and over 60 so that was why she thinks she was prescribed medications for COVID. She had a rescue inhaler that expired and her doctor sent a rescue inhaler and have used a couple times since she got sick. Albuterol rescue inhaler.; "Allergy induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "recovering" and all described as "came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received concomitant medications as Multivitamins. Nurse is the patient who had completed primary series of COVID-19 Vaccines and the week she was planning to get Omicron booster she came down with COVID and treated with Paxlovid. Caller confirms details provided by transfer agent. Her physician is not going to know anything as she did a virtual care visit to get medications for the COVID. She took her last dose of Paxlovid this morning and finishes steroids tomorrow. Patient did not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient did not visit Emergency room.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2.
I'm convinced that I was exposed at my workplace as we have had a number of positive COVID-19 cases there and I have been extremely careful over the past few years. My symptoms began on Sunday, 07/10/2022. I dismissed them for a few days because they presented very similarly to pollen allergies and I was treating them as such until they became more pronounced on Tuesday. On Tuesday evening, I took an at home COVID-19 test which was immediately and clearly positive. I took another at home test to confirm and it was also positive. I have been in isolation since then. I called my doctor on Wednesday to request PAXLOVID. I did not hear from them until the next day 07/14 and they provided me a number for a telehealth type visit. I called that number and was prescribed a modified version of PAXLOVID for people with renal issues. I am unsure of why I was prescribed this specific sort and am waiting to hear back from my doctor on that matter. I began taking the PAXLOVID that evening. My symptoms had already began to improve and the side effects from the PAXLOVID were actually more pronounced than COVID-19 symptoms. At this point my symptoms have all improved and I am cleared to return to work tomorrow.
After shot right arm just hurt for 2 days. On day 3 started to get bumps and rash on wrist, back of legs, thighs, day 4 hives/rash allergic reaction looking hives on skin ... started to be very itchy and burning the rash..... red.... called pharmacy advised to take Benadryl . After 4 hours hives moved to lower back small spots on stomach... waiting for the hives/ reach to go way... Day 5 now
Pt received FLUVIRIN MDV. After a few minutes claimed did not feel well. Throat was scratchy-felt like throat closing-called 911. After a few minutes administered EPIPEN in left thigh.
Chest pain that started the evening of the vaccine administration, intensity 6/10 on the evening of and all of the next day.  Has persisted more mildly with waxing and waning intensity since for the last 2 days.
Information has been received from a physician concerning a 16 year old female patient who completed GARDASIL series. The patient was HPV positive prior to receiving vaccine as sexually active. A few months ago the patient experienced positive PAP tests for carcinoma in situ. The physician did a "cone procedure" and now her PAP was clear and she was considered recovered. The patient sought medical attention via going to office. The physician considered positive PAP tests for carcinoma in situ to be an other important medical event due to cone procedure. This is one of several reports from the same source. Additional information has been requested.
Patient came back after 14 days stated that Flu-Shot gave her HA, shaky hand, body and gas her stomach, sweating too. Cannot sleep since have the shot.
Patient received Zostavax vaccine for shingles on 2-2-2009. Patient lost hearing in right ear, developed swollen neck glands and growth in nasopharynx. Patient diagnosed with non-Hodgkins lymphoma 04/29/09.  Patient now receiving chemotherapy.  7/24/09 Medical records received DOS 2/20/09. Zostavax administered.
pt had no Adverse reaction. patient recieved Moderna Bivalent on 11/09/23. pt then recieved a 2nd dose of the Moderna Bivalent again on 01/30/23. on the day of 1/30/23, pt realized that she may have recieved 2 doses of the bivalent.
Hives began 2 weeks after the booster. They are worst in the morning and evening. Benedryl helps relieve them but then they reappear again at the same times each day moving to different places on my body. I?ve had wheezing that goes with the hives.
This case was reported by a nurse and described the occurrence of injection site soreness in a 14 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting, 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.
Information has been received from a consumer concerning her daughter who was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient was broke out with chicken pox. The outcome was unknown. It was unknown if the patients sought medical attention or not. No further information is available.
Pt complains of flushing, light headedness, and hot flash.  Pt provided apple juice, graham crackers and allowed to rest while MD consulted.  Event occurred at 11:19 am, Vaccine received at approx 10:55 Am
Patient woke with a fever the next day.  As progressed, she c/o feeling tired, chills, left arm sore with rash at injection site. This morning(06/06/2019) she noticed a lump on left clavicle.  Per her PCP, she was told that this is a reaction to the injection.  Pending outcome.
felt close to pass out; extreme weak; confusion; loopier; second dose of the Moderna Covid-19 vaccine after recommended dosing interval; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt close to pass out), ASTHENIA (extreme weak), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (loopier) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna Covid-19 vaccine after recommended dosing interval) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high. Concomitant products included CAPTOPRIL, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE + CAPTOPRIL) and ATENOLOL for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna Covid-19 vaccine after recommended dosing interval). On an unknown date, the patient experienced PRESYNCOPE (felt close to pass out), ASTHENIA (extreme weak), CONFUSIONAL STATE (confusion) and FEELING ABNORMAL (loopier). On 13-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna Covid-19 vaccine after recommended dosing interval) had resolved. At the time of the report, PRESYNCOPE (felt close to pass out), ASTHENIA (extreme weak), CONFUSIONAL STATE (confusion) and FEELING ABNORMAL (loopier) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Blood pressure measurement: other (Low) 67/51 low. and other (Low) after salt intake- 74/51 mm Hg..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took some salt to treat the symptoms  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non-Significant FU (Attached updated snapshot)
SORE ARM THE DAY AFTER; VERY TIRED; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not provided. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm the day after, very tired, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight headache, very tired and sore arm the day after was not reported. This report was non-serious.
My daughter received her first injection of GARDASIL 07/28/11. Within days of the first injection she experienced hives. The hives presented themselves every few days, the average being 2 maybe 3 times a week. She received the second injection 09/28/11 within days the hives were presenting themselves on a daily basis. She is now on medication daily to control the hives. The medication should be lasting 24 hours however the drug can only fend off the hives for about 8-10 hours, in some cases even a shorter period of time. She is now taking a pill twice a day which could affect her liver/kidneys. Quite often she is woken in the middle of the night by the hives which interrupts her sleep schedule. The only way to lessen the severity of the itching and pain is to take a tepid shower and to remain as still as possible. The hives also interrupt her daily school and activities schedules. The hives are large (hand size) lesions that look like large water blisters and protrude from the surface of her skin. The hives cover the entire body; torso, legs, arms, feet, hands, face and lips. Her hands, feet and mouth/lips swell with no visible patch. Immediately following the first onset of hives we took her to an Allergist. The Allergist ordered lab work to determine if this could be an auto-immune disorder (other than type 1 diabetes) and environmental influences. The lab work reflected she does not have an underlying auto-immune disorder that could trigger the hives and there is not an environmental cause the doctor thinks could be triggering the hives. We also began a food log at home. However our family is organic and our food brand/type hasn't changed in years along with detergents, soaps, etc...
Patient recieved HPV vaccine. Patient did not eat before she came in. Informed patient to sit down for 5 to 10 minutes to make sure she felt ok. Mother insisted they had to leave. I informed mother that if patient did not feel well to have her lay down immediately. As patient was walking out of the room the mother yelled for my name. I approached patient and mother was holding her sitting up on the ground. As I approached patient was fainting with seizure activity. I immediately placed patient flat on the ground. After a few seconds patient started to recover. After 30 seconds patient was fully recovered. BP 124/61. Patient laid for a few minutes. Sat patient up BP 116/80. Stood patient up BP 117/74 and walked patient to car. Notified patient to lay down if she starts to not feel good again and to go to ER or 911 if patients does not recover. Also informed patient to eat when she gets up in the morning.
Varicella and MMR where given within 10 days of a previous MMR, no adverse reactions seen as of this time.