chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is now deceased.  ED 11.20.21; hospitalized 11.21.21; COVID-19 positive (11.20.21);  fully vaccinated Admitted for hypotension, septic shock, COVID-19 (with ESRD, cardiomyopathy, bilateral PE) Admission Date: 11/21/2021 Date of Death: 11/23/21 Time of Death: 12:59 PM Preliminary Cause of Death: Hypotension DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shock (HCC) [R57.9] Hypotension [I95.9] HOSPITAL COURSE: This is a 77 year old male with a PMH significant for HTN, HLD, ESRD on HD, T2DM with retinopathy & neuropathy, gout, hemochromatosis, hyperparathyroidism, cardiomyopathy, OSA on BiPAP, CAD and obesity who was brought to the emergency department on 11/20 by EMS from his care facility with concerns of hypotension. The patient was noted to be hypotensive on initial evaluation and was given Levophed, also found to be positive for COVID-19 and noted to have CT thorax findings of large right effusion unchanged from prior imaging, increasing moderate left effusion, as well as patchy airspace disease in the right upper lobe and right middle lob suggestive of pneumonia representative of changes secondary to COVID-19 with inflammatory changes and early bacterial pneumonia. There was also question about the possibility of a PE on the CT thorax, however it was deemed unlikely as the patient had been anticoagulated with Warfarin for Atrial Fibrillation with therapeutic INR. The patient was started on broad spectrum antibiotics for bacterial pneumonia and was started on Remdesivir and Decadron for treatment of COVID-19 with admission for further evaluation and management. On the first full day after his ER visit that led to admission, the patient had elected not to pursue treatments any further. Hospice was consulted and patient/patient's family ultimately elected for inpatient hospice. Nephrology had been consulted for assistance with the patient's dialysis, although they ultimately signed off the patient's care due to patient choosing not to pursue further treatment and deciding to pursue inpatient hospice care. During the patient's hospitalization, his ICD was turned off given the patient's decision for hospice care. The patient was kept comfortable with the help of hospice during the remainder of his hospitalization and he expired comfortably on 11/23/21 with his wife and son at bedside. The patient was pronounced expired at 12:59PM on 11/23/21.
Patient came in for his flu shot on 10/04 and returned a few days later to report that his arm was still feeling sore and that he felt that the vaccine was administered too high in his left deltoid by staff. No reports of redness, swelling or anaphylaxis however patient reports what he feels to be pain in his joint which developed after he received his flu shot. He is currently experiencing pain when lifting his shoulder/joint and has set up an appointment with his doctor for follow-up.
Poor quality vaccine administered with no reported adverse event; products were not good and needed to be returned with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves 30 patients received poor quality vaccine ACT-HIB post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect hib (prp/t) vaccine Powder and solvent for solution for injection lot UJ756AAA , Expiry date: 12-Aug-2023) (strength, dose: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered), products were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  It was reported Nurse manager reports that 30 doses of ACTHIB and 3 doses of MENQUADFI were administered to patients post-excursion; she asks if they need to re-vaccinate their patients?  At time of reporting, the outcome was Unknown for both events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 04-JUL-2013 the patient was vaccinated with an expired dose of ZOSTAVAX lot # 0168AE, expiration date 06-MAR-2013, (strength, route, dose number were not reported). No adverse symptoms reported. Additional information has been requested.
Wt loss, vomiting, diarrhea, anorexia. 04/04/08-office notes for 3/27/08-Assessment:possible mild rotateq vaccine reaction. Diarrhea began on 3/25/08-Appetite decreased. Restless, irritable.
This spontaneous report was received from a 31 year old female patient, referring to herself. The patient had none pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 15-MAR-2017, the patient was vaccinated with GARDASIL or with GARDASIL 9 0.5 ml once (lot # and expiration date were not reported) therapy route reported as injection for prevention of human papillomavirus (HPV). Approximately on 22-MAR-2017 (reported as within a week), the patient started feeling lethargic and started losing hair like crazy (alopecia). The patient sought medical attention, she did not receive any treatment but she had an unspecified blood work (results were not reported). At the time of this report, she had about 40 % of her hair left and she had not recovered from both events. The patient was looking for reimbursement for the vaccine as well as compensation for medical expenses.  The causality between the events alopecia and lethargy with GARDASIL and with GARDASIL 9 was not provided. Additional information has been requested.
Patient received the wrong vaccine. Patient filled out a consent form to receive his 3rd Engerix-B. The prescription was processed through correctly and the patient was checked out at the register. At administration, a 4th year pharmacy student who is not employed by pharmacy administered a Moderna COVID booster that was intended for another patient. The student reports asking the patient verification questions but the patient denies this. The patient reported that he still wanted the Engerix-B dose so that was given. Patient had completed his Pfizer COVID series and was due for a booster in January.  The patient was given the appropriate paperwork to document the Moderna COVID booster that he received.
Right shoulder swollen, red rash over whole shoulder, cannot lift arm, painful to touch - started day after immunization; two days after IMZ using icepacks, BENADRYL, and ibuprofen for 5 hours now, hasn't gotten any worse.
About 28 hours after receiving my second dose, I started to develop chest pain and discomfort throughout my chest. It felt like an intense pressure inside of my chest. Nothing seemed to make it better. Leaning forward might have decreased the pain slightly, but not much. I was thinking that it was Myocarditis, so I self medicated with 600mg of ibuprofen. About an hour and a half later it subsided. It made the pain go from 6/10 to 2/10. I took more Advil in the morning to help because it came back. This lasted for about 3 days. I was also experiencing heart palpitations. I was experiencing the palpitations daily, up until July, and I still experience them from time to time, but they aren't severe.
Patient had just received Tdap, Hep A, MCV4, MMR, & Varicella vaccines.  He was sitting down waiting while his sister sat on the exam table waiting to receive her shots.  About 2 minutes after receiving his vaccines, pt complained, " I don't feel so good."  He looked pale, so I instructed him to get up on the exam table and to lay on his side.  I gave him a safety sucker to slowly suck on.  About 30 seconds later, he began to have a generalized tonic clonic seizure.  I removed the sucker from his mouth immediately and assured a patent airway.  The seizure lasted less than 5 seconds, and patient maintained pink but pale color.  He was alert immediately following the incident, answering my questions appropriately.  He did complain that he "felt drunk" and was sl grey pink.  BP 98/58  HR 69 @1755.  Continued to have patient lie down until his color was normal.  He stated he felt normal at 6:00 pm and wanted to sit up.  His color was normal, so I allowed him to sit up, but continued to monitor him until 6:15, at which time his BP was 94/54 and pulse was 62.  His color was pink, and he was alert and appropriate. Mom reports that patient has a history of epilepsy, but has not had a seizure or meds in 10 years.  Advised her to have patient examined by his primary physician the following day (8/7).
After the shot went home and went to sleep woke up the next morning with my whole face was swollen and hives and I could not see my because my face so swollen, it lasted 3 days went to the doc and they gave me a shot to take the swelling away.  most of the swelling has gone but my eyes are swollen 3 weeks later.
Patient left Consultation Room without cane accompanied by Lady friend. They proceeded to shop in the aisle of the store, then came back to Pharmacy Waiting area after 10 to 15 minutes. Patient complained of neck and shoulder pain. She sat down. I asked if she wanted me to call 911 she said yes. She had no complaints of allergic reactions. No wheezing, no redness, was able to speak clearly. EMTs arrived urged patient to go to ER, but patient declined. I spoke to her about 3 to 4 hours later via phone, she was fine.
I had a light heart attack but heart Cath 4 days later showed no signs of plaque, no blockage, no unusual complications. I am in very good health with no precedent conditions.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Administered the vaccine after 30 day by use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after 30 day by use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after 30 day by use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after 30 day by use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after 30 day by use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant medications were reported.   The patient received half dose. The vial did not undergo any temperature excursions.  No treatment details were reported.
This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Injection site pain from start. At 4 am,  had chills, nausea, and lightheadedness. I felt tired the whole day with off and on symptoms previously mentioned. Feel fine today (05/08/2021)
Vomiting and vomit had blood in it; Bloody nose; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 10 FEB 2021, the patient received her second planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm and administered by medical center for prophylaxis of COVID-19 infection.  On 11 FEB 2021, in the morning the patient woke up with a bloody nose, vomiting and the vomit had blood in it. The treatment information for the events, were not provided. The patient had other medicine for her blood pressure and toe fungus.  The action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the events, bloody nose, vomiting and the vomit had blood in it were considered as unknown.; Reporter's Comments: This report concerns a 61-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273, Lot number: 032L20A) and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis. Very limited information regarding these events has been provided at this time.  Further information has been requested.
The following day after the first dose was administered, my left arm has been tingly and numb constantly. Time was 3/25 morning and continues today 4/12.
This case was reported by a pharmacist via call center representative and described the occurrence of helicobacter pylori infection in a 67-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th August 2018, immediately after receiving SHINGRIX, the patient experienced generalized rash. In August 2018, the patient experienced helicobacter pylori infection (serious criteria GSK medically significant). The patient was treated with Amoxicillin and Clarithromycin ER. On an unknown date, the outcome of the helicobacter pylori infection was unknown and the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the helicobacter pylori infection and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The pharmacist reported daughter of the patient called and reported he had his injection of SHINGRIX and right away experienced an all over body rash. The rash had not resolved. The patient also mentioned he was placed on an antibiotic for Helicobacter pylori infection and the onset date of this was unknown. The pharmacist stated she noted to the daughter this rash was frequent with antibiotics but the daughter noted it was before starting the antibiotic. The patient was placed on Amoxicillin 500mg and Clarithromycin ER 500mg for the Helicobacter pylori infection. This case has been linked with US2018147981, reported by the same reporter.
3 inch area around injection was erythematous, indurated, and itchy for 2 days post injection
My husband got first dose of Moderna on 2/16/21 without any side effects.  He got the second dose on 3/16/21 and after 10-12 hours had fatigue, myalgias and nausea which resolved within 10-12 hours.  HOWEVER, one week after second dose, on 3/23/21, my husband took a shower and noticed shortly thereafter around 8 AM a itchy rash on face and neck.  NO rash over Vaccine Site.  Over the day the rash got more intensely red and noticed blotches over his upper chest (symmetrical oval patches just beneath each nipple region).  He took 2 Benadryl Tabs at night and in morning of 3/24 the rash has improved considerably..  The rash was macular and erythematous and never raised with no blistering.   His first dose of Moderna was on 2/16/21 and lot number was 011M20M.
Severe, intense h/a; better next day; 9MAY94 noticed brusing easily; In for 5th dose; bitten by a horse that was sacrificed p/10 days; unk if tested for rabies; will do CBC & check platelet count;
Pt received VARIVAX on 12/5/12 -> noted 1st lesion on forehead last night 15 hrs before visit -> new lesions continue to appear this morning - has > 30 lesions at visit -> vesicles on pink base, first lesion crusting.
injection site getting swelling; injection site getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red). At the time of the report, VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not reported. Concomitant medication was not reported.
Chills, sweating, nausea, dizziness, vomiting, fever up to 102
This spontaneous report was received from a nurse refers to a male child of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PROQUAD (lot # K007800, and expiration date 29-NOV-2015) subcutaneous in the left arm. While administering the vaccine the hub of the needle was not twisted down and half of the vaccine leaked out around it. So only half of the 0.5 ml dose was administered. No adverse effects reported. Nurse stated that he will re administer the vaccine. Action taken was not applicable. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as the reporter did not wish further contact.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.  No treatment medications were reported.
Lethargy, weakness, incontinence, cough, SOB, chest tightness
Pt given MENVEO without incident. During administration of GARDASIL vaccine, pt complained of pain and then passed out. Nurse and mom helped lay patient down. Patient with urinary incontinence and then awake again. Episode <2 minutes. No postictal state. Normal neuro exam. Pt went home after further monitoring without any additional incident.
PATIENT RECEIVED A PFIZER VACCINE INSTEAD OF A MODERNA FOR HIS SECOND DOSE.
Swelling/red, fever, nausea, sleepy x 3 days, chills.
A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the reporter stated that, patient was allergic to the vaccine and has been advised to not take the second dose. The reporter asked that If a person doesn't take the second dose of the Covid vaccine, is it harm to the body. The reporter stated that was watching the show, Expert, which is a Christian program, and they were stating that the vaccine takes away the ability of the placenta. The reporter heard that 99% of people get over the Covid virus.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.