chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician and from a Registered Nurse refers to a 12 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient had 2 days of vaginal discomfort, minimal. On 12-SEP-2012 ("last night"-reported on 13-SEP-2012), the patient noticed several spots in vulva somewhat pruritic but mostly uncomfortable. The reporter requested information on possible vulval ulcerations after receiving the GARDASIL. No treatment information was reported. It is unknown if the patient sought medical attention. The outcome of several spots in vulva somewhat pruritic but mostly uncomfortable is unknown. The relatedness for 2 days of vaginal discomfort, minimal, several spots in vulva somewhat pruritic but mostly uncomfortable was not reported for GARDASIL. Additional information has been requested.
Patient continued clearing her throat 10 minutes post injection, and her voice became hoarse. She stated her had a little difficulty swallowing. She also stated her throat was dry, so she had water. She educated on use of an epipen but she refused. She wanted to leave and use her inhaler, but was told unsafe to leave, She was told if she did not use epipen or inhaler she would have to go to ED, she used inhaler and stayed for additional observation and showed improvement
Pt. c/o redness and itching X2 days at site  5X3.5 inches (+)
Fever of 102, lethargy, crankiness, then a day or two later, rash/speckles on her face and then a few on her belly.
Improperly stored administered vaccine; This spontaneous report was received from a office manager and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 14-JAN-2021, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # T010309 , expiry date 24-MAR-2022, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported).  Digital data logger was involved. The vaccine underwent the temperature excursion at -8.5 degree of Celsius (C) to -10 C for 1 hour and 35 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
Patient woke up the morning after receiving his Flu vaccine with redness and swelling and itching in his upper right arm. The second day after receiving the vaccine the entire upper arm and redness, and swelling.
hyperactivity; increased appetite/ Voracious appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 14:15 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "autism" (ongoing), notes: Onset Date: Birth; "GI Reflux", start date: Aug2013 (ongoing). Concomitant medication(s) included: PREVACID taken for gastrooesophageal reflux disease, start date: Sep2013 (ongoing); CLONIDINE taken for autism spectrum disorder, start date: Oct2021 (ongoing); RISPERDON taken for autism spectrum disorder, start date: Sep2019 (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease, start date: Sep2013 (ongoing). Vaccination history included: Bnt162b2 (Dose:1st, Time: 16:45, Site and Route of injection:, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 18Nov2021, for COVID-19 Immunization. The following information was reported: PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 28Dec2021 22:00, outcome "recovered", described as "hyperactivity"; INCREASED APPETITE (non-serious) with onset 28Dec2021 19:00, outcome "recovered", described as "increased appetite/ Voracious appetite". Therapeutic measures were not taken as a result of psychomotor hyperactivity, increased appetite.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a 16 year old female who on 13-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# 659653/1448U). On unspecified date the patient developed a fever of 100F, congestion, coughing. The date and lot numbers of the first two doses were not provided. Unspecified medical attention was sought by calling office. The patient was advised to take ADVIL for relief of symptoms. At the time of this report the patient did not recover from her experiences. No other symptoms or treatment reported. No other information available. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician and medical assistant concerning a 17 year old female who on 13-MAR-2008 was vaccinated into right arm with her third dose GARDASIL (lot# 659653/1448U). On 17-Mar-2008, in the morning (4 days post vacciantion), the patient developed a fever of 100F, congestion, coughing. The dates and lot numbers of the first two doses were not provided. Unspecified medical attention was sought by calling office. The patient was advised to take ADVIL for fever and ROBITUSSIN for cough and call office if no improvement within 24 hours. It was reported that the patient's mother had reported that on 18-MAR-2008 (next day) the patient recovered from her experiences. No other information available. No further information is expected.
ED to Hosp-Admission Discharged  2/16/2021 - 2/17/2021 (28 hours)    Last attending o Treatment teamObesity, morbid, BMI 50 or higher (CMS/HCC)  Pulmonary nodules  COVID-19  Diverticulitis  Diarrhea due to COVID-19 Resolved    Hospital Course     HPI: is an 34 y.o. female.  Complaining of abdominal pain.  The pain is primarily left side.  She does have a history of diverticulitis in the past.  She was diagnosed with Covid about 2 weeks ago and has been having fevers initially and diarrhea which have now subsided and she is changing to abdominal discomfort.  She denies any fever but did have nausea and vomiting Saturday.  She has not required any supp
Tornado hit in the county resulting in a temperature excursion.  Verification via manufacturer performed; however, wording not understood that vial was considered activated since vial had been punctured and a dose removed.  Office was contacted by consultant that medication was considered activated since the vial was opened prior to the excursion and should not be used.  Re-verification with the manufacturer performed.  At that time, it was noted dose was considered invalid and patient would need revaccinated.  Parent contacted and aware.
Redness at injection site, itching, mild swelling, area felt hot and painful. She was told to take an antihistamine and apply a cold compress to the area.
Patient called and states visible knot at injection site, no bruising, not red, not hot to the touch, just a raised area.
Mother reports prolonged crying for 3 1/2 hrs after injections. Afebrile, ate well resolved spontaneously. Void and stooling WNL.
1st vaccine - no effects 2nd vaccine - within 12 hours, injection site pain and localized swelling; 24 hours, fever of 101F orally, chills, headache and nausea.
One day after HPV9 given on 4/18/16 pt said she got dizzy, lightheaded and passed out at school. Dr examined pt. and stated she had vasovagal attack and possible reaction to vaccine just had headache on AM of 4/20/16.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and tenderness at injection site continuing now to 7 days post vaccination. The date of onset unknown. The severity was unknown and it was unknown whether the patient had used pain relievers or sought medical treatment.
10/11/12- 4 vaccines given. 30 minutes later syncopal episode, tachycardia. BENADRYL given. Revived 30 minutes later, collapsing w/severe tremor, pallor, tachycardia. EMS called, transported to hospital. EKG, CBC, Chem, U/A. Friday, 10/12/12 - office visit at doctor. Eyes swollen, headache, muscle pain, pallor, body ache. Flu and Strep tests negative. Friday evening - Headache worsened, very severe; sent back to ER, admitted by Dr. Saturday, 10/13/2012 - discharged to home from hospital. Sunday, 10/14/2012 went to hospital. Treated for dehydration. Had dizziness, headache, body pain. Monday, 10/15/2012 seen at Dr. office. Headache now gone, hydrated and happy.
Sx (x3 days) soreness after receiving injections then the day after shots given. Patient noticed (2) red spots that have now grown into one large plaque very painful, no drainage, no chest pains, no dyspnea, no nausea or vomiting or diarrhea, no fever. These red spots are medial upper arm. Not at shot injection site. Treated with doxycycline hyclate 100 mg bid x 14 days.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine  and advised lot 007B21A  maintained activity needed to protect against covid 19  at time vaccine was administered. Also patient did not call in to complain of adverse event. This is administrative error without adverse event.
vaccine made me sick; This case was reported by a consumer via and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the first shingle shot and got sick. The patient need to get his/her second shot soon.
sore arm at site of injection; Fatigue; Body aches; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the left arm, on 17Feb2021 (Lot number not reported), at age 54 years old, as dose 2, single, for COVID-19 immunisation, at a public health department. The patient was not pregnant at the time of vaccination. Relevant medical history included high blood pressure, controlled from an unknown date, not reported if ongoing or not. The patient has no allergies to medications, foot or other products. Concomitant medications included spironolactone and venlafaxine both taken for unknown indications, start and stop date not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) administered in the left arm, on 27Jan2021 (Lot number not reported), at age 54 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Feb2021 07:00, the patient experienced sore arm at site of injection, fatigue and body aches. No treatment was given for the events. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHE; DIZZINESS; FEVER; HEADACHE; DIFFICULTY SLEEPING; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included premature baby, and concurrent conditions included asthma, and very thin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:45 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced difficulty sleeping. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body ache, and the outcome of dizziness and difficulty sleeping was not reported. This report was non-serious.
Injection was Wednesday afternoon. I slept the entire day Thursday following the injection. My symptoms included tiredness, lethargic with fever, sweating heavily from fever, loss of appetite, dizziness, pain at injection site, swelling and redness at injection site that is hot to the touch. Diarrhea as well, though that may be from taking acetaminophen for the fever without food. Today, Saturday, so 3 days after injection, I had a low grade fever in the morning (7am) with dizziness, took acetaminophen, and the fever and dizziness went away around 10am and has not returned. I also no longer have loss of appetite. Acetaminophen is the only thing I have used to treat the symptoms (fever and pain). I was unable to eat Thursday into Friday until 5pm. I called an on call nurse at this time to confirm I did not need to be seen. Last night/this morning I woke around 3am with some nausea. I still have diarrhea as well as pain, swelling, and redness at the injection site. The redness is a defined splotchy patch, about 3 inches by 4 inches on my left shoulder. It is very hot to the touch and touching it is very painful. I have applied a cool wash cloth a few times, but it is painful to touch.
Patient's father said in was hard as a rock, swollen, and warm to the touch. Patient's parents took him to the Dr.'s office. Patient's father said Dr took a picture of it and prescribed Diphenhydramine and Ibuprofen.
she experienced burning throughout her body from head to toe; felt weak; shaky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6206) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot: EN9809), administration date: 12Feb2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "she got burning in left arm/she had burning sensation in her arm where she received her injection on the left side", "It went up to her ear on left side/she had burning sensation in her arm where she received her injection on the left side and went up to her ear". The following information was reported: BURNING SENSATION (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "she experienced burning throughout her body from head to toe"; ASTHENIA (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "felt weak"; NERVOUSNESS (hospitalization) with onset Mar2021, outcome "recovered" (Mar2021), described as "shaky".   Additional Information: After the second dose, she experienced burning throughout her body from head to toe, felt weak and shaky. Those effects lasted 20 minutes. Caller wants to know if it's going to be worse with the booster dose. Now, she is real concerned about getting the booster. She heard that whatever you  experience with the first two, the third will be worse. She stated that she almost went to the hospital with the second one.  It was reported that, if patient received a Booster Shot so far, reactions reported after getting a booster shot were similar to those after the two-dose or single-dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects, and overall, most side effects were mild to moderate. However, as with the two-dose or single-dose primary series, serious side effects are rare, but may occur.  Follow-up attempts are completed. No further information is expected.
acute resp distress; Dyspnea; unable to talk in complete sentences; diffuse wheezing; This is a spontaneous report from a contactable Physician. A 60-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in the left arm on an unspecified date (at 04:00 PM) at single dose in left arm for covid-19 immunization. Medical history included PCN (Penicillin allergy). The patient was not pregnant at the time of vaccination. Concomitant medications included PPI, Thiazide Diuretic, ARB, Muscle relaxant in two weeks. The patient had no other vaccine in four weeks. The patient previously received Metformin and Neomycin, both experiencing drug allergy. The patient reported dyspnea in the post vaccination observation area. Noted to be in acute resp distress (no angioedema noted) unable to talk in complete sentences, diffuse wheezing on auscultation with poor air entry noted." All events started from Feb2021 04:00 PM. AE resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for events, including EPI x 1, IM Steroids, PO Antihistamines, PO Steroids tapered dose. No covid tested post vaccination. Outcome of the events was recovered.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events acute resp distress and Dyspnea in this 60 year old female patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Discharge Provider: MD Primary Care Physician at Discharge: Clinic Physician, MD None Admission Date: 3/29/2023  PRESENTING PROBLEM: Shock [R57.9] Severe sepsis [A41.9, R65.20] Typical atrial flutter [I48.3]   HOSPITAL COURSE: Patient is a 65 y.o. F with a PMHx significant for AML, T1DM, Hematochromatosis, CAD, HTN who presents to the ED for chief complaints of generalized weakness/fatigue as well as shortness of breath. She states that she developed these symptoms starting on 3/24/2023. She denies any fevers/chills, along with any urinary symptoms. She admits to productive cough. She states that she had tested positive for COVID-19 with home test on 3/28/2023. She presented to the ED with worsening symptoms. She was recently hospitalized from 3/2-3/8/2023 for sialoadenitis of the L. Submandibular gland, she completed a 10 day abx for her condition.  In the ED her vitals were significant for tachycardia and hypotension. Her labs revealed Na of 127, Lactic of 5.8, Pro BNP of 7365, Troponin og 26, WBC of 1.97 (ANC of 1.12x10^3), TSH of 6.38 w/ normal T4. Her CXR did not show any acute process. She was admitted to the MICU for persistent vasopressor needs. Overnight on 3/29 she started to develop severe lactic acidosis and was unable to provide respiratory compensation. She was intubated for work of breathing. CRRT was started for severe acidosis and oliguria. ID was consulted and started Cresemba, prophylactic acyclovir, and empiric PO vancomycin. On 3/30/2023 - 3/31/2023 overnight family discussions took place, patient's worsening condition was discussed along with worsening  vasopressor needs. She also had worsening metabolic acidosis. DPOA ultimately changed code status to DNR after reviewing these conditions with the care team. During the afternoon of 3/31/2023 at 1:20 PM she was pronounced deceased.    Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Fatigue, weakness, GI discomfort, diarrhea for 24 hours.
MANUSTRIAL CYCLE HAS BEEN AFFECTED AND MANSTRATION IS HAPPENING IN TWO WEEKS AND THTEE WEEKS INSTEAD OF THE USUAL MONTHLY
Feeling very cold, 102.6 fever, chills, uncontrollable shaking, and sweats
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 904 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
KINRIX given to patient at 4 month well check and is not recommended in children under the age of 4 years.
Slow onset of fatigue starting around 7pm. Appetite fine, but heavy body feeling, body aches, feverish feeling (fever unknown). Took 800mg Ibuprofen around 8:30pm with excellent results and relief from body and severe pain at injection site.  Nausea and queasiness slow onset around 11:30pm. Took Mirtazapine and went to bed around 12:30am.  Woke up at 9am and have general pain at injection, body aches, particularly in the forearms, biceps, and lower back. Feverish feeling (fever unknown), fatigue, chills, neck soreness (more on the left).
A week after receiving the COVD19 vaccine, red patches of skin started appearing around the injection site.  Patches were not itchy.  Armpit area (lymph nodes) was painful, as well as general pain in left arm.  The next day the rash had gotten larger and left arm started tingling.  Arm pain persisted.  On the third day the rash was larger still, with prolonged arm tingling and left chest area pain.  I went to the ER as no one could answer why these problems were arising  a week after the vaccine.  ER advised taking Benadryl and watching out for shortness of breath.  Arm is currently tingling and eyesight seems fuzzy.