chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 76 year old female patient, referring to herself. The patient had a concurrent condition of diabetes and a medical history of left breast cancer in 2003 (reported as "15 years ago"). Her concomitant medications included metformin. On an unknown date in 2012 or 2013, the patient was vaccinated with a dose of ZOSTAVAX injection in the right arm (dose, lot number and expiration date were not reported) to prevent shingles. On an unknown date, "sometime after the vaccination", the patient developed a painless rash on her right leg above the knee, which was diagnosed as mild shingles and was treated by an unspecified oral medication (reported as "some type of pill"). The patient recovered from shingles approximately 2 weeks later. On an unknown date in 2015 (reported as "3 years ago"), the patient experienced a relapse of the cancer. She also stated that at the time of the report, the cancer was in her lymph nodes. The event was treated with IBRANCE (reported as "IBRANZ"), however it caused an unspecified event that "almost killed" the patient and was subsequently switched to capecitabine. The patient sought for medical attention. At the time of the report, the patient did not recover from the cancer relapse (it was still being treated). The relatedness between the events of shingles, cancer relapse and cancer in lymph nodes and ZOSTAVAX was not reported. The reporter considered the event of unspecified adverse event that "almost killed" her to be related to IBRANCE. Upon internal review, the events of breast cancer relapse and cancer in lymph nodes were considered to be medically significant.
Chest pain, tachycardia up to 140s,  difficulty breathing, numbness
Patient received 2nd dose of Moderna Covid vaccine at approximately 9:00am. 15 minutes later she started to feel dizzy and complained of chest pressure. She then experienced a syncopal episode with lasted approximately 45 seconds. This patient has not experienced a previous allergic reaction to the first dose. She developed an itchy red rash on her right and left arms. She also reported nausea. In the emergency department, she received Solu-Medrol 80mg, Benadryl 25mg, 1L of NS fluid, Pepcid 20mg, and Zofran 4mg. She was discharged to home via wheelchair once stable. At the time she was discharged, patient was awake, alert, and oriented x3. Patient verbalized understanding of disposition. She was given prescriptions for promethazine 25mg and ondansetron 4mg.
A non-serious, spontaneous report of Flu has been received from a registered nurse concerning a 12-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 25-Sep-2009. On 06-Oct-2009, the patient experienced fever, sore throat, cough, congestion, and tiredness. The patient went to the doctor and tested positive for the Flu. The event outcome was not reported.
two people who got their booster they died; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the first of two reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter knows of two people who got their booster they died on an unspecified date. It was unknown if autopsy was done.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392251 Same reporter/drug/AE and different patients.; Reported Cause(s) of Death: two people who got their booster they died
Woke up on fourth day with extreme headache at 4:00 in the morning. Went back to bed, got up at8:00 , took shower and got very dizzy and nauseas . Sat on edge of bed and got up to throw up and passed out on bathroom floor.  Husband  called 911 and was unconscious for about 3 minutes. Was taken to hospital , did cat scan, bloodwork, no other findings but Dr said it could be reaction to vaccine. Got concussion still having dizzy spells.
Patient was fully vaccinated. Sinus congestion started 7/25/21. Tested positive for Covid on 7/27/21.
pt recv vax;devel myalgias,shivers & a local rxn;tx w/ meds;
hot to the touch at the injection site; red; Swelling; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (Swelling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient sought treatment from a doctor and she was prescribed cephalexin, but had not started taking it at the time of this report.
Child with bronchitis. Tested by PCR positive for Bordetella pertussis.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted while immunizer was giving vaccine to another patient. Patient's friend found him on the floor while she went to purchase water. Patient recovered and was conscious when Immunizer came out. Offered water and food because patient said he felt light headed. Did not call EMT. Patient left after few minutes when immunizer went out to check,
A few days p/vax pt exp malaise & devel fever; 22NOV91 pt hospitalized w/bilateral optic neuritis & transverse myelitis; Pt exp loss of vision & weakness & paralysis of lower extremities; d/c 3DEC91; pt recovering vision but paraplegic;
Small red area which over time became 3.5 inch erythema when observed 8/20/12, had quarter size area of pale skin with small scab, upper Rt arm, went to Dr 8/20/12- Dr dx reaction to vaccination, prescribed Zyrtec and Benadryl cream. 8/21/12 parent called and noted area was improving.
Patient received COVID vaccine dose #1 and after 10 minutes began to feel faint.  Patient's face was pale. Patient was laid on the floor with feet up, He laid for 15 minutes and sat up slowly, pulse and respiratory rate were normal. vaso-vagal response most likely
2 hours after vaccines given left lower extremity from hip to Ankle was completely red; Right thigh was red. 30 min later entire Right lower extremity was red. 4 hours after vaccines given legs were normal except a few petechiae in lower legs.
Pt came to ER c/o fever, chills, body aches, fatigue, SOB, nausea, and vomiting.
The morning after (5/3/2018 Thursday morning) the injection patient experience a red rash at the site of injection which was hard and sore. On Friday 5/4 rash got bigger. The rash started to go away slowly and it was gone by Monday 5/7.
Got Td injection in left deltoid. C/o warmth at site, and knot at site, tenderness to touch. Has been rubbing with alcohol and taking Tylenol. Instructed to apply warm compresses, take Advil as directed on bottle, d/c using alcohol and F/U with her MD next week if not better.
The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis.  Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home.  Baby was seen in the office today and appeared happy with a normal abdominal exam.  Passed a normal BM today.
10/26/2022. Patient presented to COVID Clinic for Bivalent Moderna Vaccine. Patient previously received Moderna Monovalent Primary and Moderna Monovalent Booster without issue. After vaccination she reported blotchy red and itchy hands. She reported history of allergic reaction to nuts but denied history of severe reaction or anaphylaxis. She stated the red and itchy hands was the same symptom she had with previous allergic reactions. She also reported some ?burning? in her chest. She later reported that she forgot to take her Omeprazole today.  She denied dizziness, lightheadedness, shortness of breath, chest pain, abdominal pain. BP check was 148/78 and pulse ox was 96% per the RN. Patient has a history of hypertension. The patient took 25mg Benadryl from her own supply.  The patient?s significant other was present with her during the clinic.  Instructed patient on use of Benadryl to manage mild symptoms of allergic reaction. Instructed her to go to the ED right away if she experienced shortness of breath/difficulty breathing, throat closing, or any concerns of worsening reaction. She verbalized understanding. Instructed her to call her physician today to follow up related to the reaction. Instructed her to check with her doctor before getting any future doses of COVID vaccine and advised that if physician approved future COVID-19 vaccines that patient should be vaccinated in a doctor?s office so she can be more closely monitored.  Patient was observed for 30 minutes post vaccination. She reported improvement in redness/itchiness in hands and in heart burn like symptoms. She further reported that she ?felt fine.? She verbalized understanding of the above education and denied any further questions. 10/27/2022. Spoke with patient and she reported the symptoms from the previous day have resolved.  She has been taking Benadryl regularly.  She has a call out to her physician and plans to see the physician for a regularly scheduled appointment on 10/31/2022. She was advised to discuss the situation with her physician. She denied any current questions or problems at this time.
Muscle soreness onset in 6 h, lasting for 2 days, self-limiting unilateral left axillary lymphadenopathy onset on day 4, lasting for 3 days, self-limiting.
Pt exp convuls in car w/mom while eating crackers & drinking bottle; mom had grandma call paramedics-convuls lasted approx 4min; pt was taken to ER w/fever 104.2 R;
Significant erythema from right shoulder to elbow and noted area of arm 2 cm by 2 cm erythema on left mid arm
Patient received dose of moderna vaccine on 4/16/21 and did not report dose to pharmacist on questionnaire.  It was discovered that patient received dose after jannsen vaccine was given and pharmacist was logging information.  Patient was instructed to contact physician for further follow up.
Localized swelling, redness at Rt deltoid site where Dtap #5 was given on 6/24/10, warm to touch and itchy, no pain. Pt was seen here 6/26/10 and advised cool compresses prn, BENADRYL prn and to call if worse or if fever developed.
CHOLECYSTITIS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a physician concerned a 31 year old male. The patient's weight was 113.6 kilograms, and height was 183 centimeters. The patient's past medical history included: open fracture of radius and ulna -right arm, asymptomatic arrhythmia, asymptomatic/benign cardiac murmur, recreational use (3,4-methylenedioxymethamphetamine), cocaine use, sternal border pain, food-borne gastrointestinal illness, walking pneumonia, upper respiratory infection, and cannabis use, and concurrent conditions included: antibiotic allergy, intermittent back pain, attention deficit disorder, cold sores - oral inside cheeks, intermittent sinus infection, biaxin allergy, and heart murmur. The patient previously used doxycycline, salbutamol and codeine (guaifenesin cough syrup) for walking pneumonia and amoxicillin for upper respiratory infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 0.5 ml, dose number in series was 1, 01 in total was administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In JUL-2021, the patient experienced elevated blood pressure. On 15-DEC-2021, the patient was seen in an ER (emergency room) for abdominal pain, diagnosed with acute cholecystitis (grade 3 severe AE (adverse event)) (dose number in series was 1) and then hospitalized. An abdominal CT (computerized tomography) scan showed gall stone. Cholecystectomy was performed on 16-DEC-2021. He was hospitalized for 2 days. The procedure was uncomplicated and the patient was discharged from the hospital on 17-DEC-2021. On the same day, his treatment medications included hydromorphone hydrochloride (Dilaudid).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cholecystitis on 16-DEC-2021, and elevated blood pressure on AUG-2021. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20220109570.; Sender's Comments: V0-20220122740-covid-19 vaccine ad26.cov2.s- Cholecystitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
One day after vaccine pt had red, itchy rash in axilla, abdomen and groin - pt also takes many medications but none were new at that time. Patient treated with oral steroids and rash resolved.
Patient's wife reported patient being nauseated and vomiting this afternoon after flu shot. She explained they did go to a restaurant after the flu shot. The patient ate, she did not. She feels fine.
Flu symptoms: fever, chills, nausea, tired for 12 - 18 hours.
stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) 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 concomitant medication details was reported. No treatment medication details was reported.  Company comment: Very limited information regarding the dates of administration of the product and the serious unexpected event of Cerebrovascular accident has been provided at this time.   This case was linked to MOD-2021-294128, MOD-2021-294118, MOD-2021-294118 (Patient Link).; Sender's Comments: Very limited information regarding the dates of administration of the product and the serious unexpected event of Cerebrovascular accident has been provided at this time.
At about 5:00 PM, pt. c/o chills, decreased appetite, slight swelling at injection site, & mom noticed glassy eyes but no fever, and gave ibuprofen. Pt. didn't sleep well during the night & awoke with same symptoms, as well as shivering with chills & tingling in right arm. Her temp was 98.1 & mom gave ibuprofen.
Rash on chest; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had a rash on chest. The patient asked could the shot cause a rash in other areas of the body.
FEEL SICK; HEADACHES EVERY DAY/HEADACHES COME AND GO; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus headaches. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, since the booster the patient had headache every day. The patient reported that, the headache come and go, but enough that at times feel sick (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches every day/headaches come and go and feel sick was not reported. This report was non-serious.
After receiving the 2nd dose of the COVID-19 vaccine on 03/02/2021, the patient states today that she had chills yesterday starting in the morning. She said she has no chills this morning. She states that her arm where she received the 2nd dose of COVID-19 (left deltoid) is pink, warm to the touch (can feel warmth through clothes), and tender to the touch. She said her husband will use a marker to mark the borders of the area of concern on that arm to see if the borders change with time. I notified Dr. of this information. I notified her that Dr. recommends she place heat on that area of her arm and to call us if any further symptoms develop. She also said she will notify us if she develops a fever 03/04/2021.
Patient previously had a Tdap shot in 2019. The provider advised to give Tdap at 8/16/2023 visit, but after administering the vaccine saw that the patient should not have gotten that vaccine until a later date. No adverse reaction happened and patient and parent were advised it was given early, but that it would not harm the patient.
devel red, pustular, pruritic rash on trunk, noticed approx 24hr p/vax;was treated w/atarax & betamethasone ointment;
PATIENT WAS GIVEN ZOSTER VACCINE INSTEAD OF VARICELLA.  NO SYMPTOMS.
sore arm (arm of the injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (arm of the injection)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included LISINOPRIL, HYDROXYZINE, PREGABALIN (LYRICA) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm (arm of the injection)). On 07-Mar-2021, VACCINATION SITE PAIN (sore arm (arm of the injection)) had resolved.            Additional concomitant medication reported by the patient was acid reflux medication.  Treatment of events was reported as none.   This case was linked to MOD-2021-075280 (Patient Link).   Reporter did not allow further contact
Apro 5 mins after vaccines were administered, child became very dizzy and was shaking. He was then placed to lie supine BP93/53 P74. After lying for about 2-3mins he no longer felt dizzy but complained of being hungry so was given sips of apple juice. At 9:40AM BP 109/69 P76 client in sitting position denies any dizziness or nausea but still shaking, however the shaking looks more like frequent uncontrollable twitching. Client alert and oriented so was allowed to have breakfast. At 10:02AM  BP107/59 P 83. Client states that he feels fine after having his breakfast. Body still shaking/twitching but less frequently and not as strong as before. Client continues to be oriented and speaking to mom clearly. After a few moments he is allowed to stand and walk around office with no trouble but twitch continues to be noted occasionally. At 1010AM Client was taken to clinic pediatrician for evaluation prior to being discharged from the clinic. Pediatrician cleared him and client left the office with his mom alert and oriented with mild occasional twitching at 10:21AM.
DIZZINESS OR LIGHT HEADEDNESS; PAIN LOWER BACK; WEAKNESS; This spontaneous report received from a patient concerned a 45 year old female. 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 not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced dizziness or light headedness. On 03-JUL-2021, the subject experienced pain lower back. On 03-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness or light headedness, weakness, and pain lower back. This report was non-serious.