chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 05Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Time (24 hr): 2 P.M, Anatomical site of injection: Left arm, Batch/Lot number: EN6198), administration date: 26Feb2021, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Time (24 hr): 7 P.M, Anatomical site of injection: Left arm, Batch/Lot number: EL9262), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 23Feb2022, outcome "unknown", described as "hip replacement".  Clinical Course: Drug lot number and expiration date: Do not have I was given the' 'Renal''-friendly dosage. Patient age at time of vaccination: 71-years-old.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004786 Same reporter/patient, different vaccine dose number/AE;
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the paperwork from the pharmacy listed her dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) as 1mL (for clarification). On 28Sep2017, the patient experienced joint/hip pain, muscle pain, fatigue, flu-like symptoms, burning in legs and she was starting to get a sinus infection. Outcome of the event of burning in legs was recovered on an unspecified date in 2017, while outcome of the other events was unknown.
Patient was given a full dose of Moderna instead of a half dose booster. Patient was notified they were given a full dose of Moderna instead of a half dose booster and was briefed on what to expect. Patient states he understood and was monitored for an additional 15 minutes. Patient indicated they were not experiencing any symptoms. No further action taken.
soreness in injection site; muscle pain; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to the company on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Red oval on arm; Arm hurting; A spontaneous report was received from other health care professional concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurting/ pain in extremity and red oval on arm/ erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced arm hurting and noticed big red spot nine days later, on 9 Jan 2021. On 09 Jan 2021, the patient noticed red oval on arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm hurting and red oval on arm was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events,  and excluding any other etiology, a causal relationship with the event cannot be excluded
mom called, & reported that pt was unresponsive, limp, not breathing, had a pulse; breaths given, compressions not necessary went to ER;
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of ROTATEQ orally (dose, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
This is a spontaneous, non-serious report received from a patient via a company representative. A patient of unspecified age, sex, height and weight received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: unknown/not reported), dose and start therapy date: not reported, for immunization. No past medical history, concomitant medications or concurrent conditions reported. On an unspecified date, patient had effects a couple of weeks later after vaccination. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of having effects a couple of weeks later after vaccination: not reported. The company is unable to perform follow-up to request batch/lot numbers.
5 days post vaccination patient developed a DVT on left lower leg, and was put on Eliquis, anticoagulant therapy
PT COMPLAINED OF SORENESS AND REDNESS AROUND THE INJECTION SITE ON THE LEFT ARM. THE REDNESS HAS SPREAD OVER THE PAST 5 DAYS. PT WAS ADVISED TO VISIT THE PRIMARY CARE PHYSICIAN AS SOON AS POSSIBLE AND LET THE PHARMACY KNOW WHEN THIS HAS BEEN DONE.
Redness, hard area, warm to touch at injection site. Pt was seen at UC, and treated with abx on 06/30/2013.
Developed bloody stools one week after receiving first dose of Rotateq. Continues to have bloody stools. Endoscopic diagnosis of Lymphonodular Hyperplasia of the colon.  01/30/07-records received and reviewed from Clinic for DOS 9/28/06-01/11/07- 1 month old visit assessment: esophageal reflux without evidence of esophagitis. On 11/2/06-mother taking clindamycin for mastitis, child developed explosive diarrhea and diaper rash. At time of Rotateq vaccine 11/14/06-some nasal congestion. On 11/20/06 patient congested not eating much. On 11/27/06-Two diapers had gross blood and mucusy material. Eating well, afebrile, no emesis and no diarrhea. No abdominal distention KUB: shows no focal abnormalities. Rotazyme positive. Numerous fecal WBC. Guaiac strongly positive. Assessment: Hematochezia. Suspect either cow's milk enteritis or early presentation of gastroenteritis. 11/3/06-Develped loose watery stools spitting up more than usual.  Stool positive for Rotavirus. No hematochezia. Afebrile. Assessment: acute gastroenteritis, resolving. 12/11/06-Two stools with streaks of blood after several normal stools.  Assessment: Hematochezia. Likely residual effect of Rotavirus. However, many of her symptoms overlap with cow's milk colitis. 1/3/07:Stools now yellow in color and quite watery, no visible blood. Negative for occult blood. Colicky type pain. Barium enema on 12/31/06 showed nodularity involving the entire colon. Flexible sigmoidoscopy showed diffuse nodules. Biopsies are normal with no suggestion of inflammation or allergy.  Assessment:Hematochezia. Lymphonodular hyperplasia noted on sigmoidoscopy, probably etiology for Hematochezia. Possible postinfectious gastropathy. 1/11/07-Recurrence of grossly bloody stools. Spit up small amount of milk.  Assessment:lymphonodular hyperplasia, colon. Per information received from annual follow up, doing well now. Follow up received 04/09/2007. I suspect the rectal bleeding was cow milk colitis, but the timing of vaccination makes ROTATEQ a possible cause.
53 year old adm 12/2. 4 weeks ago, the patient given the flu vaccine (1st time) and developed a productive cough, myalgias, fevers (as high as 100), and a sore throat. Patient given azithro. Symptoms continued so patient we to ED. CXR (+); ? pneumonia. Patient given another course of azithro and felt better. Approximately 1.5 weeks PTA, patient noticed a pruritic area on the back of her right arm and right thigh. The lesions started to swell to approximately 1 cm in size. PMD increased her prednisone. Lesions became purple and patient diagnosed with new anemia. Patient awoke on 12/1 with painful LE lesions. Patient started on stress dose steroids. Morphine given for pain. ESR=76. Systemic vasculitis secondary to the influlenza vaccine suspected. Bx: c/w hemorrhagic skin necrosis. Most likely antiphospholipid precipitated by the flu vaccine.
I've been experiencing dizziness and vision issues fir the past 7-10 days. I also have developed Vitiligo, or what appears to be Vitiligo, on my hands... first noticed around March 31, 2021.
Cold like synptoms-post nasal drip; enlarged lymph nodes; sore throat; sore arm; general malaise; runny nose; wheezing; This is a spontaneous report received from a contactable other health care professional (patient him-self). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9269) via an unspecified route of administration to Left arm on 19Feb2021 12:15 at single dose for COVID-19 immunization. Patient medical history included ADHD, Anxiety, Depression, Psychosis, Ashthma and seasonal allergies. Patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On 19Feb2021 15:00 patient experienced with Cold like symptoms- post nasal drip, sore throat, sore arm, enlarged lymph nodes, general malaise, runny nose and wheezing. Patient did not receive any treatment for the events. Outcome of events was not recovered.
Late second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Late second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PRODUCT DOSE OMISSION ISSUE (Late second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Late second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Pt. presented to school nurse with red rash around the outside of his mouth on both left and right side. School nurse documented pt. pulse ox at time was 98 and heart rate was 104. The patient ate a packed lunch from home around 11:15 am. Guardian was notified and came to school to pick up pt. Guardian was advised to take pt. to  primary care provider for assessment. Pt. did return to school on the next day school was open which was 10/21/19.
Pfizer / BioNTech  dose 1-4, Treatment of COVID-19 start date: 13Jun2022; Pfizer / BioNTech  dose 1-4, Treatment of COVID-19 start date: 13Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), on 07Mar2021 as dose 2, single (Lot number: EN6207), on 30Aug2021 as dose 3, (booster) single (Lot number: FC3184) and on 07Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE; LOSARTAN; SIMVASTATIN; LYRICA; AMLODIPINE; CALCIUM; VITAMIN D NOS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech dose 1-4, Treatment of COVID-19 start date: 13Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Positive, notes: did not test for Covid until Sunday the 26Jun2022 and tested positive for Covid; (01Jul2022) Positive, notes: and patient still testing positive on 01Jul2022 though any symptoms were gone. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid on 13Jun2022 to 18Jun2022. it was reported that on Friday 24Jun2022 patient started having lots of sinus drainage that settled in his chest quickly, but he thought it was a sinus infection and did not test for Covid until Sunday the 26Jun2022 and tested positive for Covid. Patient isolated again and was still testing positive on 01July2022 though any symptoms were gone.
lot of mucus after the Moderna Covid-19 vaccine; developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson vaccine (The patient developed a severe blood clot in her eye and a severe rash on her neck. Rash went down her arms to her elbow and the rash lasted for several months.) in March 2021 and Johnson vaccine (The patient developed a severe blood clot in her eye and a severe rash on her neck. Rash went down her arms to her elbow and the rash lasted for several months.) in March 2021. Past adverse reactions to the above products included Clot blood with Johnson vaccine; and Rash with Johnson vaccine.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.). The patient was treated with CORTISONE at an unspecified dose and frequency and CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (lot of mucus after the Moderna Covid-19 vaccine) and RASH (developed a rash after her booster dose,The rash is on her back,neck, and part of her head.rash after the moderna Booster dose is not as severe as the rash was after the Johnson and Johnson vaccine.) outcome was unknown.            No Concomitant medication was reported. treatment medication liquids, ointments,  antihistamine.   Patient says that she is in her sixties. The patient went to a Dermatologist and started to get better. Sleeping was difficult.
every year the patient got some form of the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020. This case involves a patient of unknown demographics reported that every year the patient got some form of the flu (influenza), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported every year the patient got some form of the flu (influenza) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Information has been received from a nurse concerning a 22 year old female who on 12-MAY-2008 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly.  The nurse stated that on 02-JUN-2008, the patient called the office stating that her arm had been painful at the injection site for the past 3 weeks.  At the time of the report the patient was not recovered.  Additional information has been requested.
I got the shot & was given the Shingles/suspected vaccination failure; was given the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot was given by the care workers in the nursing home that were not clean. The patient inquired were shingles ever bad and still had shingles and they act up every once and a while. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Varicella vaccine breakthrough. Diagnosed with varicella on 8-14-07. Had T-100 for 2-3 days and approximately 20 vesicles with some crusting.
Pain to right thigh/ walking to left thigh; She has also been feeling chills and cold all over; She has also been feeling chills and cold all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. Patient reported side effects that she experienced after taking the vaccine on 23Mar2021 and 14Apr2021. Pain to right  thigh which came and went on the 28Mar2021 like lightning, and 03Apr2021 while walking to left thigh. She has also been feeling chills and cold all over since the 1st vaccine shot on an unknown date in 2021. The patient was on PRN prescription of Valtrex 500mg wants to the know if the efficacy of the Pfizer covid 19 vaccine will be affected if she took it after taking the second dose of the Pfizer Covid 19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HAD COVID TWICE; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. 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 experienced had covid twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had covid twice was not reported. This report was non-serious. This case, from the same reporter is linked to 20211256286. This report was associated with product quality complaint: 90000208731
Pt recvd 3 doses of Engerix-B & it was determined that pt did not seroconvert; 4th dose of Engerix-B was administered;
Mom relates 2-3 episodes occuring 1Mar91-pt had clear mucus discharging from her nose& mouth,threw up hands& became rigid.Pt repeated episode 1 time 2Mar91.Taken to Hosp suctioned& sent home.Repeated episode again 1 time 9Mar91..see WORM
This spontaneous report as received from a physician via Company Representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). Physician reported that after administering ZOSTAVAX an anonymous patient developed a "chicken pox rash after 3 to 4 weeks." The physician also reported a second reaction on patient's leg that happened later. It was not sure what second reaction entailed. The outcome was unknown. Additional information has been requested.
Headache; Nausea; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced fever, headache and nausea. On an unknown date, the outcome of the fever, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The reporter unsure if vaccine administered intramuscularly, the volume, and lot number, expiry date of vaccine. The patient complains of 103 degree Fahrenheit fever that developed a week later that lasted approximately 5 days.  The reporter also reported less than 2 weeks after vaccination headache and nausea. The patient not considering for receiving 2nd dose. The reporter consented to follow up.
Adverse event: Vaccine administered 16 days after beyond use date and less effective. Treatment: Pt is receiving another dose in office as recommended by Pfizer and the state.
Patient tolerated all vaccinations well and denied any adverse reaction to receiving vaccinations.  Patient received Measles, Mumps, Rubella, Varicella (MMRV) vaccination and Varicella vaccination on the same date.