chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 10 year old female with allergic rhinitis, asthma, allergy to cherries and no known drug allergies/reactions, who was vaccinated with the first and second dose of GARDASIL on 06-AUG-2010 and 01-DEC-2010 respectively (dose, route and lot # unspecified). On 01-DEC-2010, patient also received a dose of MENACTRA and a dose of FLUZONE (manufacturer unknown). Concomitant therapy included ZYRTEC and albuterol. The physician reported that the patient developed a small rash following the first injection with GARDASIL (approximately in August 2010) with no reporting lasting effects. Following these injections: second dose of GARDASIL, a dose of MENACTRA and a dose of FLUZONE (manufacturer unknown), the patient developed full blown urticaria. Patient was given BENADRYL and corticosteroids (manufacturers unspecified). No lab diagnostic studies were performed. Therapy with GARDASIL was discontinued, as patient did not receive the third and final dose as a result of the adverse experience. At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 10 year old female student patient who on 06-AUG-2010, was vaccinated into the right arm with the first dose of GARDASIL (lot # unspecified) and on 01-DEC-2010, was vaccinated intramuscularly into the left arm with the second dose of GARDASIL (Lot# 666597/0768Z, expiration date unspecified). It was also reported that on 01-DEC-2010, the patient was also vaccinated with a dose of ADACEL (Lot#C3476AA) intramuscularly in the right arm, a dose of MENACTRA (lot#U3507AA) intramuscularly in the right arm and a dose of influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated)) (Lot#U3641AA) intramuscularly in the left arm. The physician reported that "following vaccine on 06-AUG-2010", the patient developed wheals, redness and pain. On approximately 01-DEC-2010, the patient developed generalized itchy wheals. The patient was seen on 02-DEC-2010 and was given BENADRYL and prednisone. Therapy with GARDASIL was discontinued. At the time of the report the patient's outcome was unknown. Generalized itchy wheals was considered to be other important medical event because the patient required medical/surgical intervention. Additional information has been requested.
currently taking antibiotics for her strep throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS STREPTOCOCCAL (medically significant), outcome "unknown", described as "currently taking antibiotics for her strep throat". Therapeutic measures were taken as a result of pharyngitis streptococcal.  Clinical information: Caller, 70 years of age, was getting ready for her third dose of the Pfizer COVID-19 vaccine, Caller was currently taking antibiotics for her strep throat. The caller wanted to know if she could take the booster or if she needed to complete her antibiotics by tomorrow. created manual form because the caller mentioned that she had a sore throat and getting ready for her third dose (adverse event in between doses).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325135 same reporter, different dose and event;
While giving  injection Vanish Point syringe malfunctioned and leaked at hub.  Partial vaccine leaked down pt's arm.  Approx 0.1 cc given IM .  Full dose of 0.3 cc IM given.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received form the same source. Additional information has been requested.
Tested positive for COVID 19 after receiving vaccinations; Tested positive for COVID 19 after receiving vaccinations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: FL3246), on 11Feb2021 as dose 2, single (Lot number: FL3302), on 21Sep2021 as dose 3 (booster), single (Lot number: FC3189) and on 31Mar2022 as dose 4 (booster), single (Lot number: EK9896) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALIGN (ongoing); CITRACAL + D3 (ongoing); VITAMIN B12 AND FOLIC ACID (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Tested positive for COVID 19 after receiving vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID 19 after receiving vaccinations; Negative, notes: She clarified she is COVID negative now. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid for the treatment of COVID-19.
Information has been received from a 68 year old female patient with lymphedema and emphysema referring to herself. The patient was allergic to "CLE+". In 2005, the patient was vaccinated with one dose of pneumococcal vaccine (unspecified) (dose and route unknown). On 03-OCT-2015, the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route unknown, in the right shoulder) at her local drug store, without consulting her physician. Concomitant medications were unspecified. On 04-OCT-2015 (reported as "the following day"), the patient began to experience chills and flu-like symptoms. When she removed her bandage, it was "full of blood", and an unspecified amount of time later, her arm began to swell below the injection site. Her arm was sore to touch. She also stated she could not lift her right arm to put on her coat. At the time of report, the patient did not seek any medical attention. No treatment was given for the events. Her chills had resolved. The outcome of other events was reported as recovering/resolving. The causality between the events and PNEUMOVAX 23 was unspecified. Additional information has been requested.
Staff member was vaccinated with a high dose formulation of the Fluzone Quadrivalent vaccine, but is not 65 years of age or older.
Hurt his back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hurt his back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced BACK PAIN (Hurt his back). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hurt his back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
I am sterile now because of your product; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY MALE (medically significant), outcome "unknown", described as "I am sterile now because of your product". Additional information: Consumer stated, "Well see that's the thing. I just have a couple of questions that I am very concerned about because I have taken the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine) and I just find out that Pfizer Vaccines have this substance called Squalene. Would Squalene make, scientifically makes men (Number of patients were not available over the call hence, spilt could not be made) sterile and I was just want know how come we were not informed about this vaccine having Squalene, sterile making a substance in it and everyone taking whose it as far as men though a sterile men because of the vaccine. So who can I talk to about this? It's very important. So, basically the COVID-19 Vaccine having this substance called Squalene in it. Squalene makes you, make men sterile. I have taken the Pfizer Vaccine. Now I am sterile because of that but yet we were not informed about this sterile making a substance inside vaccines and there is no word of it. Why is that? The Squalene is the substance that makes men sterile. Squalene is inside the Pfizer Vaccine. The Pfizer, you know Pfizer just know the government, informed everybody before people took the vaccine especially the men that have the sterile making substance called Squalene inside the Vaccine. Now I am just curious why is that nobody including especially Pfizer never said a word about this and informing everybody that before you take the vaccine be careful because you going to be sterile afterwards. That's what I was trying to figure out. When you sterile, you sterile for life. There is no one who knows expiration date on the vaccine. The vaccine has got me sterile for life because of the substance called Squalene that nobody warned us about when the vaccines came out alright which makes you sterile forever. I am forever sterile. I mean that's understood there is no expiration on that."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Anaphylaxis, started with dizziness, followed by increased perspiration, drop in BP, pallor, cold extremities. Given epinephrine 1 mg/ml 0.4 ml IM with improvement in BP within 1 minute, resolution of other symptoms within 2 minutes. Observed in the clinic for 30 minutes afterwards
Soreness at shot sight. Headache, body aches. Tiredness. Low grade fever. Nausea and loss of appetite
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested.; Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA008820: US-009507513-1708USA011857:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002920 with expiration date of 30-SEP-2018, lot # M018625 with expiration date of 11-AUG-2018, lot # M035487 with expiration date of 23-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (33F) for 3 hours. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided.        This is one of several reports received from the same reporter.      Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001232:
Got hep B three injections 10/16/99, 11/24/99, 5/2/00 total. My arm swelled and heat for 3 months after second shot.  bowel changes and urination. Then I received the varicella shot. 9/8/00 and on 11/12/00. I started having bloody nose constent sleep leg cramps, fatigue, bowel movements changed was in  throwing up and vertigo, dizzy, hot sweats,  By 2/10/02 very ill.  Ringing in ear constently. Double vision, vertigo, kidney failure, bowel movement changes. Everything spinning dizziness, severe headache, high blood pressure, couldn't urinate. Then I got out of hospital struggling to walk and couldn't go up steps, cold burnin in feet and leg severe point spasms when lying down like during electrically shocked. Discharge Summary received on 12/31/2003 states nausea.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 11:00AM. Patient has not reported to Medical Clinic with symptoms at this time.
Information has been received from a vaccine manager (healthcare worker) referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with ZOSTAVAX (lot number, dose and route were unknown0 that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that nine patients were administered expired dose of the Moderna COVID-19 vaccine.
This spontaneous report was received from a physician refers to unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant therapies included sterile diluent. On 07-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number: R013565, expiration date: 13-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis, which was reconstituted with properly stored sterile water diluent. The administered doses of vaccines experienced the temperature excursion of -9 to 8 degrees Celsius for 13 hours 59 minutes and -9 to 8 degrees Celsius for l hour 43 minutes. There was not previous temperature. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA003427.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: patient called 1.14.23 to report her injection site reaction. It had formed a clear large bubble with redness and swelling. Advised patient to return to Clinic for further evaluation, but she states it was already mostly resolved.
tenderness p/shot-swelling began 48hr p/vax w/tenderness & pain;came to clinic 9 days p/w /small amount residual induration 2xm x 3cm;no erythema;
Pt came into to hospital for dizzines and diagnosed with BPPV, pt went into PEA cardiac arrest pt intubated and ROSC achieved. Post code developed organ failure and need dialysis and tested positive for coivd. Pt continued to decline regardless of treatment for covid and organ failure. Family decided to withdrawl care. Pt expired on 7/17/2022
Initial report received on 9/22/06 from another manufacturer, report number WAES0609USA02156. The initial reporter was a health care professional. A 14 year old male pt, with a history of penicillin allergy, had received an injection of Adacel, lot number unknown, route and site of administration unknown, and a subcutaneous injection of Varivax, manufacturer, lot number 646670/0627R, on 7/13/06. Concomitant medications included Cleocin and Minocin. Four days post vaccination, the pt developed a rash on his ankles and legs which was red and itchy with some eruptions to the legs and arms. The skin had dew drop like blisters, and the pt was developing new lesions as the older ones crusted over. The physicians assessment was varicella secondary to the vaccine. The pt was treated symptomatically, and he recovered. The initial reporter considered this event to be an other important medical event (OMIC).
She reported having nausea and vomiting and pain, tenderness and mild swelling to her left arm.  During the week, her arm has continued to hurt and be swollen.  Today she presented with a warm, red, swollen arm that also has an area of edema around her elbow.
This case was reported by a healthcare professional via MedImmune and described the occurrence of anaphylactic reaction in an adult male subject who was vaccinated with TWINRIX (GlaxoSmithKline), FLUMIST (MedImmune) and Yellow fever vaccine. On an unspecified date the subject received unspecified dose of TWINRIX (unknown), unspecified dose of FLUMIST, unspecified dose of Yellow fever vaccine. Twenty minutes after vaccination with FLUMIST, TWINRIX and Yellow fever vaccine, the subject experienced anaphylactic reaction, hives, wheezing and bradycardia. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine. At the time of reporting the outcome of the anaphylactic reaction, hives, wheezing and bradycardia was resolved. The healthcare professional considered the events were related to vaccination with TWINRIX, FLUMIST and Yellow fever vaccine. On 25 September 2009, a nurse reported to MedImmune, received a report of a serious spontaneous report of anaphylactic reaction has been received concerning an unknown age adult, male, subsequent to FLUMIST along with Yellow Fever vaccine and TWINRIX. The subject received FLUMIST along with Yellow Fever vaccine and TWINRIX on an unknown date. The subject received a total of one dose of FLUMIST before the onset of the event. The subject experienced the event of anaphylactic reaction, hive, wheezing and bradycardia, within 20 minutes after FLUMIST, Yellow Fever vaccine and TWINRIX administration. He was treated with two doses of epinephrine. The outcome of the event of anaphylactic reaction was recovered. The reporter assessed the event of anaphylactic reaction as related to FLUMIST, Yellow Fever vaccine and TWINRIX. On 30 September 2009, additional information was received from the reporter: she submitted a VAERS report to the Center of Disease Control.
The injection site swelled significantly over several days. It was very hot to the touch and it hurt. The whole upper arm swelled.
Pain (sometimes intense) in back of skull/neck, ear pain (intermittent), disequilibrium or dizziness (intermittent), feeling unsteady at times, neck cracks and pops a lot.  This comes and goes.  I have to take ibuprofen 600 mg every 4-6 hours.  Went to chiropractor, helped neck somewhat.  Went for vacation (May 1, 2021) and symptoms went way on day 2 on vacation (there for 14 days and did drink alcohol while there, maybe numbed it ?), got back home on a Saturday (May 15, 2021) and symptoms started again on Sunday (after plane ride?), have had symptoms on and off, but mostly on ever since (today is May 24, 2021).  This affects my activities of daily living.  I worry about encephalitis (?).  I had been in good health before.  I do have Epstein-Barr and Factor V Leiden (per blood tests years ago).   I did go to my doctor April 26, 2021 ( I believe) and she did neuro testing (Romberg and finger-to-nose a little off, but everything else fine).  She gave me meloxicam for the pain in neck, helped a little, but so does ibuprofen.  So I guess you could say this has been going on for almost a month now (besides the time on vacation when I felt better).  I am getting a craniosacral massage tomorrow, but think I will also call my doctor again.
my left arch was very painful; not able to walk very well; This is a spontaneous report from a contactable 83-year-old male consumer (patient) reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 11Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Known allergies included only dogs and cats. On 11Feb2021, hour after the vaccination, the patient experienced left arch was very painful and he was not able to walk very well. The patient did not take any treatment for the events. The outcome of the evets was resolved on an unknown date.  Information on Lot /Batch Number has been requested.
Bells Palsy symptoms. Approx 13 - 14 hours after injection . Seen at urgent care treated with prednisone and valacyclovir. Symptoms lasted 2+ weeks and are minimally still present on right side of face.