chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bleeding due to crohns; back felt like had a steel plate from ribs down; bruising of the vaccine area like it was sore, tender there; bruising of the vaccine area like it was sore, tender there; felt tired/heavy because of vaccine; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344454-00 (Agency).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 03Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 2021, outcome "recovered" and all described as "bruising of the vaccine area like it was sore, tender there"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "felt tired/heavy because of vaccine"; CROHN'S DISEASE (medically significant), outcome "recovering", described as "bleeding due to crohns"; BACK DISORDER (non-serious), outcome "not recovered", described as "back felt like had a steel plate from ribs down". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "felt tired/heavy because of vaccine", "bleeding due to crohns", "back felt like had a steel plate from ribs down" and "bruising of the vaccine area like it was sore, tender there" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events crohn's disease, back disorder, vaccination site bruising and the use of suspect product BNT162B2 cannot be fully excluded. Based on known drug safety profile, the events of vaccination site pain and fatigue are assessed as related to BNT162B2.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Fever to 101, red puffy eyes, increased sleepiness emesis x 1.
Per patient's wife on Wednesday evening 9/23/15 he began to develop a rash around his neck which spread down his arms.  It looked like little red pimples and was itchy.  She said it got progressively worse until Saturday evening 9/26/15 it was so itcy he could barely stand it and was dark red.  He went to seek advice from a relative who is a nurse.  She advised that he take some Benadryl.  When she called me Sunday morning 9/27/15 he had taken 3 doses of Benadryl.  She said that it was looking a little better but was still red and itchy.  They were concerned that it could possibly be a reaction to the injection he had about 2 1/2 weeks ago on 9/9/15.  She denied that any new medications, soaps, etc. were being used.  The only change besides the vaccine was some fudge his son had brougt back from a trip.  I paged his doctor who said it was unlikely to be a reaction this far from the administration and side effects from the shingles vaccine were rare anyway, but if he were uncomfortable or getting worse he should go to the urgent care in town.  I advised patient of this.  I followed up with him this morning 9/28/15.  He said his rash was not itchy this morning and not as red, so he did not visit the center last evening.  He said that if he started to feel worse again he would call his doctor for an appointment.
A physician reported that several pts received TD Toxoids Adsorbed, Purogenated and subsequently, developed injection site reactions characterized by redness, swelling and tenderness. As of 10/9/00, no further information was available. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
complaining of ringing in the ear/tinnitus; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 84 years old female patient who was complaining of ringing in the ear/tinnitus, after she was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  at a dose of 0.5 ml once (batch number:UJ268AA, expiry date: 10-May-2020) via intramuscular route in the left arm..  On an unknown date, latency unknown, it was reported that patient has received the vaccine and has since been complaining of ringing in the ear (tinnitus). It was going on for 1.5 to 2 weeks. One of the physician told her that tinnitus was a side effect of vaccine, but the nurse believed that physician said this just to satisfy the patient.  She was give prednisone and was sent to an ENT (ear, nose and throat).  The nurse stated that this year overall, fluzone high dose had been a good batch without many reports of side effects.  Action taken was not applicable with vaccine.  At the time of this report, outcome of event was not resolved.  No further relevant information was reported.
Aching arm, loss of train of thought, deeper breathing, steady increase in heart rate with the occasional drop in heart rate.
2/23/2016 soreness, warm to touch. 2/24/2016 soreness at site/ pain to touch, hard, red, warm to touch. 2/26/2016 evaluated by doctor and antibiotic ordered. Shingles vaccine admin route of IM instead of SC.
BLOOD CLOT; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered 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 got blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534929-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on29-OCT-2021 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Left deltoid red, warm, swollen at injection site. 6 cm x 7 c m
Approximately 2 hours after vax  whole bicep area turned red and swollen. Vey sore. Arm redness is now dissipating some but still feels stiff
This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (Nasal) 18-54 µg, QID. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing). At the time of the report, DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) outcome was unknown and DIZZINESS (Dizziness) was resolving. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 87 (Low) Abnormal and 70-80 (Low) Abnormal. On 03-Mar-2021, Oxygen saturation: 85 (Low) Abnormal, 50 (Low) Abnormal and 60 (Low) Abnormal. On an unknown date, Heart rate: 100 (High) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Vaccine administered 11/7/05. Onset of vesicular lesions lower trunk and groin 11/11/05. T 99.5 seen by MD and given Rx for Atarax on 11/11/05.
Extreme swelling, redness, warm to and hard to touch. swelling started around the site of the shot, but progressed all the way to the elbow and even below within 2-3 days. It also went around the back and above the injection site. The doctor put him on BENADRYL, which seems to be helping.
Developed Shingles on 4/22/21 confirmed by medical professional and ED visit with neurological symptoms
After completion of vaccinations patient passed out momentarily. Mom had patient supported and the RN grabbed the doctor. We laid patient down. Provided crackers and water. Patient began to improve. Patient was able to sit up in the chair after 2-3 minutes.
patient stated that almost immediately injection area started itching, continued to get worse;  red, tender and itching, area getting bigger
Patient continues to have increased seizure activity and worsening respiratory status.  I have discussed the patients decline with Dr.   The family is now at the bedside and we have discussed the patients decline, they wish to withdrawal care at this time.  Will order comfort medications and discontinue current medications and the ventilator.   I was notified by the patients nurse that the patient had become asystolic and apneic shortly after withdrawal of care.  At my assessment the patient is asystolic and there is no palpable pulse.  No spontaneous respirations or breath sounds/heart sounds with 2 minutes of auscultation.  She is nonresponsive, corneal reflexes are absent.  Time of death is 1210pm.  The family is at the bedside.  I will notify the attending physician.  RN to notify Agency and funeral home.
Patient was given Pfizer Bivalent 2/23/23. The nurse was unaware that patient had a Moderna Bivalent 9/18/22. Patient monitored with no adverse reaction. Discussion with patient in regards to extra dose.
Coughing, low grade fever 99.0, red itchy rash at injection site (Benadryl).
Information has been received from a physician concerning a 74 year old female who on approximately 12-OCT-2008 was vaccinated with PNEUMOVAX (lot number: 660718/0551X) 0.5ml (route was not reported). On 12-OCT-2008 the patient developed swelling on her arm away from the injection site. Subsequently, the patient recovered from swelling on her arm away from the injection site. This is one of several reports received from the same source. Additional information has been requested.
The symptoms lasted 2 weeks: chills, fever, muscle ache, diarrhea, fatigue.
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down  with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt weak, but left leg was extremely weak and just could not get much feeling in my leg.. also left foot numbness as well. headache increased over course of the evening and into the next morning. i alternated tylenol and advil to try and help with the headache beginning evening of receiving dose. by next morning i decided to take vicodin to help get the headache under control. i then began  with vomiting  late am on 2/06. had chills, headache continued, and headahce persisted. i also had very large amount of nausea that lasted until mid to late morning of 2/07. vomiting saturday am, afternoon, and evening. unable to keep any food or liquid down at all. swallowed 3 sips of gingerale saturday pm, and vomited within 5 minutes of it. feeling to my leg gradually returned to normal on saturday (vaccine was friday). i'm doing report mostly because of the left leg symptoms and vomiting. not sure if this should be reported, so i am just reporting it.
Patient reported developing redness of her upper thighs, stomach, chest, inside of arms near elbows on day following vaccination. Reported no itching. Reported on 8/21 but claimed to be getting better.
Information has been received from a physician concerning a patient (age and gender unknown) with a history of fainting while seeing blood, who, on an unspecified date, was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced very low blood pressure, fainted, and had a seizure.  At the time of the report, the outcome of the patient was unknown.  Upon internal review seizure was considered to be an other important medical event.  Additional information has been requested.
pt recvd flu vax 12NOV95 @ work;14NOV began to have flu-like sxs aches, pains all over head/neck/extremeties;+ fever-100;felt warm w/chills;16NOV weakness began in lower extremities + tingling, numbness;17NOV could not walk;19NOV inc weak
Vomiting, intractable, lethargy, t102; HOSP x 48hrs r/o sepsis;
felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick). At the time of the report, MALAISE (felt sick) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patients received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
This spontaneous case, initially received from the other non-health professional (consumer) on 22-Oct-2018, concerns a 61-year-old, adult female patient. The patient's historical vaccine included influenza vaccine which she received every year for the past 40 years. The patient had been allergic to gelatine and beef which could cause hives or anaphylaxis. On an unspecified date in 2017, the patient was administered influenza vaccine (dose, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date, trade name, manufacturer: not reported). On the same day, few hours after vaccination, the patient experienced very large and swollen area down past her elbow which lasted for few days. At the time of report, the patient had recovered from the event. The reporter assessed this case as non-serious.
itchy; it felt like blisters; redness head spread from his deltoid down to his elbow; oozing from the injection site; arm felt tight; warm to the touch; red; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow, it felt like blisters.  The patient's medical history was not provided. Concomitant medications reported were lantus, Janumet, Glimepiride, Protonix, Atorvastatin, Telmisartan for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) oozing from the injection site. arm felt tight, warm to the touch, red, itchy. On 12 Feb 2021, the patient experienced the event(s) redness head spread from his deltoid down to his elbow. it felt like blisters.  Treatment details included Benadryl and Benadryl cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow,   it felt like blisters was unknown.
pt recvd flu vax 1230PM rash over entire body commencing @ 4Pm puritus, reddish rash, cont; MD exam 15OCT93;
BLOOD CLOTS/SLOUGHING CLOTS; MULTIPLE BILATERAL KIDNEY INFARCTS; BLOOD VESSEL INFLAMMATION; This spontaneous report received from a parent via a company representative through social media concerned a male of unspecified age, 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 and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots/sloughing clots, multiple bilateral kidney infarcts, and blood vessel inflammation. Laboratory data (dates unspecified) included: 13 Blood test shows zero clotting factor diseases or predisposition to those diseases. Treatment medications (dates unspecified) included: hydroxychloroquine.  It was reported as "our son threw blood clots and suffered multiple bilateral kidney infarcts after his shot. He's lucky those clots didn't lodge in his heart or brain...and 13 blood tests prove he has zero clotting factor diseases or predisposition to those diseases. He did have blood vessel inflammation and was forming and sloughing clots due to that damn shot.. Hydroxychloroquine was prescribed to reduce the inflammation. So far so good. How many people would still be alive today if HCQ was used in the early course of covid to treat the massive inflammation that ravages bodies in severe cases......makes me sick how big pharma and this administration have treated..... and of course, no one can be held liable...how very convenient ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots/sloughing clots, multiple bilateral kidney infarcts and blood vessel inflammation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221259540- Multiple bilateral kidney infarcts- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0-20221259540- Blood clots/sloughing clots- The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
ct findings may refelect sequelae of atypical infection; Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. This 83 years old female consumer reported in response to a non-HCP letter sent for a cross reference case that included:  A 83-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 83-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (BNT162B2, solution for injection) via an unspecified route of administration on an unknown date as dose1, single for covid-19 immunisation and experienced not feeling well that evening, chills that night, has developed a cough, heart rate went up. On 16Feb2021, he patient experienced ct findings may refelect sequelae of atypical infection, on an unknown date in Feb2021, patient experienced sore left arm. The patient underwent lab tests and procedures which included computerised tomogram: Mild scattered tree-un-bud nodularity with in the right lower lobe, new as compared to prior on 16Feb2021. Patient had biyearly CT scan of chest. The outcome of the events were unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
5 mins p/vax pt began to cough, w/inc secretions then began to wheeze & exp bilateral eyelid edema; pt sx responded quickly to Epi, Albuterol, DPH & Pred;
Immunizations given about 13:30. Mom noticed a red area at the Prevnar site at about 18:00.
Patient was administered TD vaccine on 06/25/08 and developed a local reaction of swelling, warmth and redness at injection site during the same day.  Patient was seen by the doctor and prescribed steroid medication.  During a follow up visit, patient completely recovered.