chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am having a skin reaction throughout my body on my arms, legs, between my legs (basically, all over my body). I have been scratching every since I took the 2nd dosage of the vaccine and it has not gotten any better. There is not a rash but it is very irritating. I talked to my nurse practitioner and the dermatologist (both are not giving me a lot of hope). The nurse prescribed a 7-day treatment of prednisone and the dermatologist wants me to take Allegra twice a day and CeraVe (at night and during the day, does seem to help a little bite but it doesn't help very well). He also recommend cortisone cream.
Soreness, red bulls eye at injection site, about the size of a baseball circumference. Thursday and Friday after the shot patient had a headache that kept her in bed most the day sleeping. Thursday after receiving the shot she felt like there was a tight band around her arm. She had diarrhea twice Friday after receiving the shot. The injection site is warm to touch. Saturday after receiving the shot her underarm on her right side was tender to touch.
Substantial fatigue, significant brain fog, greatly decreased lung capacity and wheezing during moderate exercise, difficulty sleeping
With interpreter present. MD stated child had high fever of 105 x 5 days with last immun. Mom then stated didn't have thermometer but was very hot. No rash or vomiting or diarrhea. Mom had never obtained PCP for child. Mom did not call HD or take child to ER. Stated she gave Tylenol x 5 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or singles. In or about 10-MAY-2013, the patient sought subsequent treatment from a physician for blistering vesicular outbreak that was diagnosed as severe herpes or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Couldn't walk; Very weak; Took the life out of her; Neck hurt for a few days; Fever; Chills; Terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Very weak), DEPRESSED MOOD (Took the life out of her), NECK PAIN (Neck hurt for a few days) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Very weak), DEPRESSED MOOD (Took the life out of her), NECK PAIN (Neck hurt for a few days), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Terrible headaches). At the time of the report, GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Very weak), DEPRESSED MOOD (Took the life out of her), NECK PAIN (Neck hurt for a few days), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Terrible headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
pt recvd flu vax & w/in 25mins pt c/o itching of lips & nose;immed p/itching pt began vomiting x 15mins;10 mins p/vomiting the pts face became very flushed & entire body broke out in a red non raised rash;pt recvd DPH & sxs subsided;
PAIN RADIATING DOWN LEFT ARM OVER TO CHEST AREA. SORENESS AT INJECTION SITE.
This case was reported by a pharmacist and described the occurrence of bilateral rash in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include breast cancer.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  It was mentioned that the subject completed radiation (for the treatment of breast cancer) on 12 October 2007.  On 14 October 2007, 4 days after vaccination with Flulaval, the subject experienced bilateral rash. On 26 October 2007, the event was resolved.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 50-year-old patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP6955), at the age of 50, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced tinnitus (like a consistent buzzing in the ear), with outcome of unknown. Additional information: The reporter stated someone in the household got the Pfizer COVID-19 vaccination, and experienced specific side-effects. Tinnitus. It was like a consistent buzzing in the ear. No follow-up attempts possible. No further information expected.
after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL; after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL; complaint is related to lack of instructions; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL"; PRODUCT COMPLAINT (non-serious), outcome "unknown", described as "complaint is related to lack of instructions".  Additional information: Reporter states her office has been administering the Pfizer BioNTech Covid-19 Vaccine after improperly diluting the vials with 2mL of the provided diluent rather than the correct amount of 1.8mL. Reporter states this was not realized until today. States shipments never came with instructions, but that the shipments are from the county and not from Pfizer.   Follow-up attempts completed. No further information is expected.
On October 14, 2010 I received this year's flu vaccination. Within 48 hours I developed a cough and cold like symptoms, no fever. The cough proceeded to worsen and at night I had post nasal drip. This triggered my asthma where for the first time since 2004 I went from being able to run a marathon to having breathing problems walking up stairs. With the intervention of prednisone and antibiotics I am just back to being able to run again. I am reporting this because my wife developed a similar cough after her flu shot the same day. Also my daughter - age 32 - and son-in-law - age 33 - who received the nasal spray version of the flu vaccine this year also developed coughs that persisted for approx. 5 weeks. While this may be coincidence I thought it worthwhile reporting as this is the first year the flu vaccine provides protection for both the regular and swine flu.
The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023; No adverse event; Patient had dose administered after 30-day Use By Date or after manufacturer date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, 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 02-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023).    Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients after 30 days use by date. The vial never underwent any temperature excursions. No adverse reaction was reported by patient at that time.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714731, US-MODERNATX, INC.-MOD-2023-714729 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714729:Same reporter US-MODERNATX, INC.-MOD-2023-714731:Same reporter
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #3 of 32, a 29 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 29 year old male on an unspecified date was vaccinated with his first dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Ten days after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of posterior uveitis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327, WAES # 1004USA02329 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medications were reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
On day three, I had redness and hot on the site. It felt thickened and it was swollen and itchy.  I got right on Cepra - Urgent Care visit like I was given for last vaccine. The symptoms subsided after four days.  I am having heart palpitations about two weeks - I notice it a lot - I notice it intermittently but often; Varies in intensity and I was woken up where my heart was beating very loudly - I tried to calm myself down because my heart rate wouldn't go down. That's never happened to me before. Even right now I can feel my heart palpate more than I should be able to feel it. Today at 01:00 PM I am going in for an EKG and have my heart monitored. I am gong to clinic where my Dr practices. I saw a PA for a work injury - for worker's comp from the vaccine -  so I have had an EKG already- result was normal rhythm acutely at the time.
Itchy rash beginning in belly button and spreading to abdomen and up torso, on back,buttocks,arms and legs.  Continues to spread in various places.  The only place it has disappeared is under arms.  Consulted doctor on 2/17.  Internist, in consultation with dermatologist, determined vaccine reaction to Moderna COVID 19 vaccine.  Prescribed Triacinolone and Allegra.  Rash is worst on back and knees.  Clustered and very itchy.
Fever (101.5), Chills, Aches, Headache, Racing heartbeat for about 4 hours and then started to get a bit better. Took Tylenol and slept. Next morning felt weak and achey, but better. Was find within 24 hours
patient with severe myalgias in left arm and left leg lasting for several weeks following the vaccine.  He also had significantly prolong redness and swelling at the vaccine site.  He also developed dyspnea
Severe chills, slight nausea, weakness, headache, weakness,  These started about 5 PM on the day I got the shot (Thursday). Sudden onset of chills.  Slept all day Friday.  Headache, dizziness, extreme weakness.  No appetite.  Saturday morning I still feel kind of weak but am able to be up and functioning. I had a similar reaction after the first shot.  Not as bad, though.
Patient experienced headaches the evening after injection, the day following vaccination patient reports dizziness, shaky legs, and face/throat numbness and tingling. Emergency room visit on 1/4/2021. Patient reports botox lip injections approximately 6 months prior.
might have a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (might have a UTI) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (might have a UTI). At the time of the report, URINARY TRACT INFECTION (might have a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was supposed to get the second dose on Thursday morning. No concomitant medications were reported. No treatment medications were provided.
BODY ACHES OVER NIGHT; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient 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 was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches over night, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches over night, chills, and low grade fever.  This report was non-serious.
Pt recv vax on 11/4/98; on 11/5/98 pt exp cramping, burning, pain on rt arm to shoulder
Initial information has been received from a physician assistant concerning a 65 year old retired female who on 06-FEB-2007, was vaccinated in the left deltoid with a 0.5 ml dose of Zostavax (Oka/Merck) (lot# "0011U").  On 26-JUL-2007 the patient developed a rash on the back of her arm.  She visited an urgent care center, was diagnosed with shingles and given VALTREX.  At the time of this report the patient's status was unspecified.  No additional information was provided.  There was no product quality complaint involved.  Follow up information has been received from the physician and physician assistant.  The patient has no known allergies.  There is a history of esophageal endoscopy (16-FEB-2006) which was normal, left ventriculography, coronary angiography, and left heart cut-down catheterization all on 06-FEB-2006 and a history of tobacco use.  There is also a history of chickenpox as a child.  There are current conditions of hypertension, diabetes mellitus (Type II), coronary artery disease, GERD, carpal tunnel syndrome, depression, and anxiety.  The patient was seen in the office on 27-JUL-2007 for her red rash which caused minimal discomfort and no burning or pain.  The onset of her rash was sudden and had been occurring in a persistent pattern for 2 days.  The course had been consistent.  The rash was first seen on her back.  The physician stated that this was not shingles.  The lesions on the right posterior shoulder were a small superficial wound which was a tick bite and two small abrasions below with mild erythema, there were no vesicular lesions.  Follow up information from the physician's assistant indicated that on 01-AUG-2007 the patient recovered.
This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursion tolerated 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Body aches, chills, starting upon waking the day after the shot and continuing until bed time Sore arm
Approximately 1.5 weeks after my initial vaccination for COVID 19, I developed 2 notable side-effects:  1) The site of the objection become slightly swollen, and itchy.  The itchiness was immediately accompanied by a reddening of the skin and a subsequent rash.  The affect was entirely localized to about an inch 'around' the site of the injection and did NOT extend to any other part of my arm or body.  2) A shortness of breath developed that -could- be compounded by a pre-existing anxiety condition.  The shortness of breath is NOT a major impediment, and simply manifests itself throughout the past two days (4-17 and 4-18) as becoming easily winded with light activity (walking) and general need to take deeper, more 'forced' breaths.
5/16 Vaccination  By 8 PM he started to have a stomach ache. He had went to bed. Went to school, was fine. Diarrhea started at home. 5:00 PM projectile vomiting. Continued with diarrhea for 20 minutes, uncontrollable. No temperature.  *Was fine the next day.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N012618 with an expiration date 21-APR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 11 days and 9 hours. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002375: US-009507513-1711USA009893.