chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BELL'S PALSY; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported. expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-MAY-2023, the patient was diagnosed with bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230603307-bell's palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Pt was contacted today by MD from hospital and the pt arrived about 1 hour earlier today after having a seizure. Says temperature is 102F (rectally) and says she has no rash, whelps, difficulty with respirations. No signs of allergic reactions and says believes temperature went up so fast as to cause seizure and that the child's dad had febrile seizures as a child. Says child seems fine now; and is to be discharged to mother's care.
Information has been received from a physician concerning a female patient who on 21-Feb-2007 was vaccinated with a dose of GARDASIL vaccine. The patient developed a single hive above her upper lip about 20 minutes after the injection. Unspecified medical attention was sought. The patient recovered. The physician did not know if the event was definitely related to the GARDSIL vaccine. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a physician and a health care professional concerning a 13 year old female patient with Penicillin allergy who on 14-FEB-2007 was vaccinated IM in right deltoid with a first dose of 0.5 mL of GARDASIL vaccine, lot #655617/1447F. The patient developed a single hive above her upper lip aboout 20 minutes after the injection. No injection site reaction or other reactions noted. The patient was instructed to take BENADRYL by mouth which she took. She recovered the same day. The physician did not know if the event was definitely related to the GARDASIL vaccine. Additional information is not expected.
Wrong vaccine was administered. Patient was supposed to be given PCV-15 but was given Hep-A instead.
Flu-like symptoms (severe fatigue, severe body aches, elevated heartbeat - near 120 BPM, normal is just over 100) from 5 AM-3 PM day after injection
Patient received shingles shot (ZOSTAVAX) on Thursday 3/10/2011 got redness at site itching & patient described it as cellulitis. Swollen, stretching feeling, red about top shape about quarter size.
COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with Covid-19 vaccine ad26. cov2.s.(manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient additional received Covid-19 vaccine ad26.cov2.s (manufacturer not specified)(suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was a covid-19 positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. (dose number series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20211229726.
pt recv vax in 1995 & exp neck stiffness;the stiffness resolved p/approx 2mo;
Information has been received from a physician concerning a 58-day-old male who on 28-APR-2008 was vaccinated orally with a first 2 ml dose of ROTATEQ (lot # 660597/0209X). Concomitant vaccines administered on 28-APR-2008 included a dose of ACTHIB (lot # OF259AA), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2951BA), dose of PREVNAR (lot # C63112), a dose of IPOL (lot # A0452-2) and a dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (lot # 657898/1622U). On 01-MAY-2008 the patient had a very small amount of blood in his stools one time only. The physician instructed the patient's mother to observe the patient and to obtain a stool sample. The patient's mother called the physician the following day and stated that the patient's bloody stools had resolved. The patient's mother canceled the patient's stool sample and reported that the patient's symptoms had resolved and the patient had recovered. No further symptoms. The patient sought medical attention via a phone call. There was no diagnostic labs performed. A product quality complaint was not involved. Upon internal review "blood in stools" was considered an other medically important event. Additional information has been requested.
1 day p/vax pt to hosp paramedic told mom pt had the measles;mom noticed rash mainly on arms & face;unk if fever present;
Pt developed a blister like rash on top of left hand about 2 hours after receiving the vaccine parents administered 2 children's chewable Benadryl child woke up this am and rash was gone.  Had similiar instance with a pertussis vaccine several years ago
Moderna Vaccine  April 14th - Recieved first shot at around 9:30 am. Stayed in waiting room 15 minutes. Was about to leave but started to feel dizzy, nauseous and a little faint. The nurse checked on me and I stayed in waiting room an extra 15 minutes till I felt a little better and went home. My left shoulder where I received the shot swelled up and was hot and bright red. My arm hurt so bad I couldn?t use it and need help to get undressed and get in bed. I took one Ibprofen.  April 15th - I didn?t sleep well because my arm hurt very bad, but I got up and went about my day.  Around 5pm I started feeling chills and it continued to get worse. I was shaking in bed and was covered with all the blankets I could find. I had terrible pain all over my body. I took 3 Ibprofen and after an hour the shakes stopped and I had a 101 temperture. I stayed in bed and took a clonazapam to help me sleep.  April 16th - I felt weak and ache and stayed in bed all day.  April 17th - I felt a little better and got up and went about my day. That evening I had 1/4 glass of red wine with my steak dinner and I also took an acylclovir (a medication I normally take but stop taking after the vaccine) and went to sleep at 11pm.  Around 1:30am I woke up out of a terrible nightmare and was seeing weird patterns when I closed my eyes. My body felt very strange, an anxious terrified feeling... my spine felt tingling and my body was writhing... I took a clonazapam and an Ibprofen, tried to watch something calming on TV, felt a bit better an hour later and went back to sleep.  April 18th - I felt weak and ache and stayed in bed all day.  April 19th - I felt a little better, 70% energy, did my work out  April 20th - Woke up at 3 am with hot flashes and headache. Feeling 50% energy, but did my workout, naped for 3-4 hours in the afternoon.  April 21st - Woke up at 3 am with hot flashes and headache. Feeling 50% energy, but did my workout, naped for 3-4 hours in the afternoon.  April 22nd - Woke up at 3 am with hot flashes and headache. Feeling 50% energy, but did my workout. Decided not to nap hoping not to wake up at 3am...cleaned house but felt very tired.  April 23rd - Woke up at 3 am with hot flashes and headache. Feeling 50% energy, but did my workout and stayed in bed all day afterwards. Took CBD oil before bed.  April 24th - Slept a little better, did my workout in the morning... felt 50% energy. Took a 2 hour afternoon nap. Rested most of the day. Took CBD oil before bed.  April 25th - Slept in till 7:30 am and didn?t workout. I felt a little better. Went for a walk and a swim in the afternoon.  April 26th - Woke up at 5 am with hot flashes. Still not 100%, but did my workout
Large red local reaction- arm redness, hot to the touch, and  swelling at the injection site on both arms . The reaction was located on both arms where vaccines were administered intramuscular.
Numbness in right foot on outside to calf, extreme pain in the Low back with no positional relief of pain, and weakness in the right sided Lower Extremity
patient was administered improperly stored GARDASIL 9; No additional adverse event reported; This spontaneous report has been received from a health care business professional (reported as: office manager), regarding a patient of unknown age and gender. The patient's medical history, previously drug reactions and allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis; lot number lot number 1780876 has been verified to be valid, expiration date reported and established as: 09-NOV-2023 (dose, formulation, route of administration, and anatomical location were not provided) (product storage error).  The suspect vaccine had a temperature excursion of 35 Fahrenheit degree with a time frame of 18 minutes. No previous temperature excursion was reported. No additional adverse event reported.
No additional adverse events reported; a dose of GARDASIL9 was administered during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S033308, expiration date 08-APR-2022, 0.5 milliliter (exact dose, anatomical location and route of administration were not reported) for prophylaxis.    Digital Data logger was not involved. The vaccine was stored at the temperature that was reported as 8.5 degrees of Celsius for 3 minutes. There was no previous temperature excursion reported.  No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a certified medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 09-FEB-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB INJ 10 Y, lot # L025738, expiration date- 14-AUG-2017 and oral, ROTATEQ, lot # L013203, expiration date- 28-JAN-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Firm, red area below injection site, approximately 2"x1 1/2" in size. Warm to touch. Symptoms appeared approximately 30 hours after injection administration. Over the past 48 hours the area has remained the same size, but has become itchy and raised.
This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 20-MAY-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since and unspecified date in April 2012.. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), on 11Apr2021 as dose 2, single (Lot number: EW0151), on 18Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 05May2022 at 17:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 51 years for covid-19 immunization. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Known allergies: food" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event- Rebound Covid 5 days after finishing Paxlovid. Confirmed with rapid test. Symptoms include sore throat, runny nose, and headache.Other medical history- Type 2 Diabetes well controlled; not overweight  No follow-up attempts are needed. No further information is expected.
>42 days since first Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
Given flu shot on 11.3.09.  Had onset of left facial swelling within 2 hours and had racing heart and  left eye swelling. Heart racing subsided shortly after onset. Developed sore throat and fever within 2 hours or flu vaccine being given. Had redness at injection site and still slightly reddened.
Began with hive like rash 5-6 hours following injection. Symptoms continued with rash transforming into peeling of skin (has been seen x 2 by her doctor).
vaccine administration error regarding Pfizer lot # FL8095 administered on12/03/ 22 with beyond use date of 08/01/22 with recommendation to get booster at local pharmacy
Moderna COVID-19 Vaccine EUA Approx. 15 hrs after shot: fever, chills, fatigue. Side effects lasted less than 24 hours.
Received Tdap 12/22/08 approximately 11am 12/24/08 11am - developed sever headache, N/V chills. ? fever, stomach pain, diarrhea. Pain at injection site, dizziness, symptoms lasted until 12/27/08. Patient did not call or seek medical care.
5/24 76y.o. male with a PMHx of T2D, HFpEF, Afib/SSS with permanent pacemaker, moderate aortic and mitral stenosis, CKD IIIb, OSA(on CPAP), HTN, and cervical vertebrae fracture (managed conservatively), who presented to the ED on 5/24/22 with a cc of acutely worsening SOB.
4hrs after flu vaccine scratchy throat, scratchy eyes. 8hrs after flu vaccine sudden onset of vomiting, dizziness and headache (R) side of head. C/o crusty exudate eyes -> chills. Woke 10/17 am with headache and LLQ abd pain.
E. COLI URINARY TRACT INFECTION; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included urinary tract infection with urinary urgency, and urinary burning.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced E. coli urinary tract infection with urinary urgency, and urinary burning. Patient prescribed Monurol to treat urinary tract infection, and her provider was concerned about interactions between Monurol and the vaccine. Per the pharmacist (reporter), the patient had been "fighting" this UTI for "awhile now" Laboratory data (dates unspecified) included: Urine culture (NR: not provided) Positive for E. Coli. Treatment medications (dates unspecified) included: fosfomycin trometamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from urinary tract infection. This report was serious (Other Medically Important Condition).       .; Sender's Comments: V0.20210333629-COVID-19 VACCINE AD26.COV2.S-E.Coli urinary tract infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
The injection site swelled into a 3inch by 3inch knot that was bright red and hot. Head, neck, chest and arms became very red. This turned into patchy hives all over and severe itchiness. I became short of breath and very congested. This worsened for 24hrs before treatment was seeked out. After treatment, the syptoms went away in about 5 days.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 17-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Suspected vaccination failure/Had the shingles vaccine, but had shingles; shingles around my left eye/shingles in forehead; residual pain over my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and residual pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the residual pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and residual pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine, but had shingles around his/her left eye and forehead, early this year. The patient still having residual pain over his/her eye. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Vomiting, diarrhea, headache, fever, fatigue . Happened around 2 hours after vaccination.  Vaccinated around 6 pm and symptoms occurred around 8 pm
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA003022, 1209USA001616, 1209USA003024). Additional information has been requested.
Approximately 1 week post first dose shot, I developed a large welt like bump at the site of injection. It was red, feverish, painful to the touch. I also had moderate pain located in the axilla of the  arm that received the injection. This lasted for 6-7 days.
Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who experienced black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 28-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA, expiry date 05-May-2019 via intramuscular route in the arm nos. On an unknown date, the patient developed a non-serious black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site (skin discolouration) (vaccination site reaction) with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was black mark on their arm from where they received fluzone hd. 5 inch in diameter, black bruise at the injection site and black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site. List of documents held by sender- none.