chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
The next day after the shot my arm was sore. The pain got worse over the next couple of months so I went to a different doctor from there on.
itching in inner ears, roof of mouth, hoarseness, tightness in chest, coughing (asthmatic), itching skin, very sore throat, some throat swelling.
Child within 12 hours followed by copious sweating and nausea along with general malaise and pain at injection site.  Two days later sharp armpit pain began with tenderness when palpated.  Pain worse upon awakening.  Four days later large rash at injection site ( left deltoid?) which is hot to touch and swollen.  Outlined borders this morning and rash has touched borders but not much more.  Alternates being painful and itchy.
Immunocompromised; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) outcome was unknown and FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.            No concomitant medications were reported. The patient experienced immunocompromised, fatigue, Fever after COVID-19 vaccine. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as solution for injection in pre-filled pen. The reporter causality for the events of immunocompromised, fatigue, Fever was  assessed as Not Reported for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 37  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of immunodeficiency. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. No further details were provided for medical reviewing. Co  suspect product Adalimumab, and Rheumatoid arthritis remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 37  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of immunodeficiency. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. No further details were provided for medical reviewing.  product Adalimumab, and Rheumatoid arthritis remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a pharmacist concerning a patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (route and lot number not reported). On an unknown date, the patient developed ataxia after VARIVAX (Merck). The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 27-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir HCL (VALTREX) and acetaminophen (+) hydrocodone bitartrate (NORCO) for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
8 hours after injection: itching, induration, pain @ injection site (left deltoid) Following morning: headache, earache & pressure,  Post nasal drip, increased pain & itching @ injection site, ping-pong sized swelling at injection site with redness. Took Motrin for symptoms with some relief.  2nd Day: improvement in pain, swelling, itching, still present. Slight headache/bilateral earache. General malaise. Took Motrin with some relief. 3rd day: left arm tender to touch, swelling/redness further decreased, intermittent itching. Malaise improved. Remnants of headache/earache.  No need for Motrin. 4th Day: arm pain/itchiness continues to decrease, no swelling now, no headache, no malaise, some ear pressure.
SkinRash & UrticariaPruritus Narrative:  treated for systemic Urticaria
pt had a positive COVID test 9/14/21; pt went into a nursing home on 10/8/21 and per death certificate she passed away in the nursing home on 10/10/21; recent COVID 19 infection was listed as a condition contributing to death
Swelling in left arm, some pain and itching. Went to urgent care facility and was advised that symptoms indicated an allergic reaction, probably to the immunizations that I had received the previous day.
Moderna COVID-19 Vaccine EUA -Patient to emergency room 1/10/21 with debilitating atrial fibrillation easily treated with Cardizem and Mg..  discharged to home within 2 hrs. with heart rate in the 90s BPM.   -HR soon stabilized to HR 100-110 BPM flutter treated 1/21/21 with cardioversion at Hospital Outpatient Surgery.  Discharged to home with heart rate in to 60s BPM sinus rhythm but irregular. Pulse Ox 94-97.  Continues to present
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of ROTATEQ (dosing details were not reported) (lot # M019706, expiry date: 24-OCT-2017) orally for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved.  Follow up information has been received on 30-NOV-2016, a call was placed to the medical assistant, but he/she was unable to provide any further information. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA005738: US-009507513-1610USA007902:, MERCK 1610USA007903:Mfr number.
Information has been received from a healthcare worker concerning a 56 year old female with a penicillin allergy and allergy to ticlopidine hydrochloride (TICLID) who on 28-DEC-2005 was vaccinated subcutaneously with a first  0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#650329/0747P).  Concomitant therapy included levothyroxine Na (SYNTHROID) and estrogens, conjugated (PREMARIN).  The healthcare worker reported that on 30-DEC-2005 the patient's "arm was red and swollen" and there were "there red welts around the injection site".  Medical attention was sought.  A methylprednisone dose pack (MEDROL DOSEPACK) was administered.  Subsequently, on an unspecified date, the patient recovered.  Additional information has been requested.
Information hs been received from a pharmacist referring to an approximately 64 years old patient of unknown gender. The patient had undiagnosed breathing problem and meperidine related allergy. On 19-OCT-2015 the patient was vaccinated with ZOSTAVAX (lot# L028281 with expiration date of 28-OCT-2015, 065 ml once, subcutaneous . Concomitant therapies included SINGULAIR. On 21-OCT-2015, the patient contacted pharmacy complaining of redness at injection site with area "about 6 inches, the size of a smaller" which happened on an unspecified date in October 2015. Pharmacist stated the patient did not report any itching at the injection site. For treatment, the patient was taking BENADRYL and applying ice to the reported injection site. No lab diagnostic studies were performed. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner, via a field representative, concerning a 65 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU, subcutaneous injection (dose, dose number, anatomical location, lot number and expiration date were not provided), administered for prevention of herpes zoster. The reporter stated that on an unknown date, the patient had a reaction after receiving ZOSTAVAX. She had two inches of redness at injection site. It was reported that the patient sought medical attention, as she visited the physician's office, however no treatment was given for the event and no lab diagnostics or studies were performed. At the time of reporting, the patient's outcome for injection site erythema and the causal relationship between ZOSTAVAX and the event were unknown.
Internal and persistent sharp/stabbing pain in left side around lungs/mid-back/thoracic area. Discomfort felt in thoracic area of back when taking short shallow breaths, and when taking deep breaths caused sharp pains in the same thoracic area of the back. Dry cough (no mucous), no blood. Occasional low grade temperatures. Pain unbearable while laying on back and side (less so while sitting, standing, or walking). Pain became so bad while driving and entering/exiting a vehicle, and 12 days of duration, decided to go to Urgent Care, which led to a recommendation to go to ER.
Patient is 79 years old with past medical history of heart failure, hyperlipidemia, atrial fibrillation, hypertension, hypothyroidism presented to the hospital with a chief complaint of fatigue and weakness associated with fever.  Patient was found to have COVID infection.  Patient has history of developmental delay and he is wheelchair-bound.  When seen, patient resting in bed comfortably.  I was unable to obtain any further history from the patient at this time.  Patient does not know where he is at.  Appears to be that is his baseline mentation. otherwise patient has no chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation, difficulty urination, dysuria.  Comfortable with no acute distress at this time when seen.   Clinical Summary   Patient was admitted to the medical surgical unit due to generalized weakness, COVID +, and UTI.  It was reported that the patient had a fall from his wheel chair at his home.  Patient has chronic indwelling Foley catheter but urinalysis was obtained and culture has resulted with Pseudomonas.  He was treated with IV cefepime which was de-escalated to Cipro to complete 7-day course.  He was also found COVID-positive, but did not have oxygen requirements.  He was evaluated by respiratory therapy on day of discharge and did not require supplemental oxygen.  He was discharged with prescription for course of Paxlovid.  His POA was instructed to hold Lipitor until completion of Paxlovid.  Discussed risk benefits and alternative with POA. Patient has numerous scrotal, peri rectum, and buttocks wounds. He was evaluated by wound care with wounds addressed. May continue to follow with wound care. Instructions for daily cleaning and barrier cream recommended.   Discharge diagnosis COVID infection Urinary tract infection Atrial fibrillation Hypertension Hypothyroidism Hyperlipidemia History of developmental delay
Case number PHEH2014US024269, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 58 years old female patient. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Cancer; Shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 9349T, expiry date 7th March 2021) for prophylaxis.   On 27th August 2018, the patient received the 2nd dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant), shingles and rash. The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation). On an unknown date, the outcome of the cancer was not recovered/not resolved and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the cancer, shingles and rash to be related to Shingrix.  Additional details were provided as follows: About 1 week after vaccination, the patient developed a rash on his ankle. He went to healthcare professional (HCP) and was diagnosed with shingles. Concerned that he had developed shingles, his HCP ran additional testing and based on those tests he was diagnosed with cancer. The HCP started chemotherapy and radiation about 1 to 2 months after the shingles. At the time of report, the patient was still undergoing treatment for the cancer.
Patient received vaccine and was sitting a chair. About 8 minutes after receiving vaccine he had a brief loss of consciousness and fell out of chair onto floor.
BRIEF OVERVIEW: Admission Date: 9/4/2023 Discharge Date: Sep 7, 2023 Discharge Disposition:  home or self care   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypertensive emergency [I16.1]   HOSPITAL COURSE: Patient is a 73 y.o. female with past medical history significant for MI, takotsubo cardiomyopathy, HTN, Afib, Aortic stenosis, CAD who presents  to the ED for N/V, cough. In the emergency department she was hypertensive with systolic blood pressure of 220, also found to be COVID-positive.  CT abdomen and pelvis showed no acute process, chest x-ray did not show evidence of an acute infiltrate. Patient was started on remdesivir x 3 days for treatment of her COVID. Hypertensive urgency likely secondary to nausea/vomiting of home anti-hypertensive and COVID. Cardiology consulted given elevated troponin on admission, thought to be likely secondary in setting of marked hypertension and resultant global myocardial strain, along with her noted COVID infection. Echocardiogram obtained and revealed EF 66%, no regional wall motion abnormalities. Patient resumed on home anti-hypertensives and started on losartan with significant improvement of her blood pressure. Patient medically stable for discharge home on 9/7.
Client called my cell phone and left message stating she had symptoms of rapid heart rate & dizziness after receiving vaccine Friday afternoon.  I spoke to her on Sunday 2/8/09.  She was still having dizziness, but denied rapid heart rate.  Pt had NS sheet and knew this was serious but refused to go to ER.  2/9/09 came to Health Dept to see Dr returned to PCP.
Pain, swelling and redness at the site of the injection lasting at least three days. Pain radiating towards the neck and the leg on the side of the injection lasting for about two days post-injection. Malaise and weakness lasting for about 24 hours following injection.
PAIN AFTER INJECTION THAT RAIDATES DOWN TO WRIST AND UNDER ARMPIT,  PAIN WITH MOVEMENT
Rash at site on both arms, legs, thigh & face. No fever. Rash lasted 5-7 days. Shot site did itch.
Hives (02/13/2021) Critically high Troponin June 26, 2021 MTHFR  Oct 2021 Exhaustion - 2/21 - current Nausea -2/21 - current Vomiting 2/21 - current Severe weakness  2/21 - current.  Headaches 2/21 - current. Loss of appetite 2/21 - current
Patient received dose at 1720. Reported nausea 1740 and went to the bathroom to vomit. Blood pressure112/80 oxygen sat 98%. Patient sat down for observation. Reported feeling dizzy. Felt better after being monitored for 45 minutes. Repeat blood pressure 120/80
Large, warm, reddened area around injection site of right upper arm. Apt with CNP on 6/6/08. Cellulitis treated with CEPHALEXIN.
My son received two MenB vaccines at the same rather than the one MenB and one MCV.  His arms were sore but no other symptoms noted.  He is also very stoic so symptoms may not be fully appreciated.  Concerned about unknown risk over time.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-OCT-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 24-APR-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
experienced upper abdominal pain about 5 hours after injection. Dull pain affected daily activity and could be experienced while walking, moving, and sleeping.  experienced sore arms (both arms) and tiredness the next day. Occasional headaches. Took Tylenol to help with side effects.
Numbness and tingling in my entire arm and hand, on the arm that I received the 1st Gardasil vaccine on, lasting at least 4 hours. Numbness is gone since I've woken up. I also noticed heart palpitations, which I usually only get from caffeine. I hadn't had any caffeine.  Pain at injection site still persists. Still watching out for other issues.
SUFFERED BY PREETY BAD HEADACHE FOR 3 WHOLE DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on JUL-2021 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 JUL-2021, the subject experienced suffered by preety bad headache for 3 whole days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffered by preety bad headache for 3 whole days was not reported. This report was non-serious.
My heart felt like it was racing, I was jittery. Back pain, shoulder pain. Arm pain where the shot was. Lower back hurts sometimes shoots into my chest.  When the pain hurts it feels like the pain is coming from my back and shoots into the front of my chest.  It makes it hard to breathe. I went to the ER from work. The ER asks me if I had Covid, and I told them I didn't think so I was never sick.  They told me to contact my PCP, and she told me that I could take a muscle relaxer at night to help me sleep.  Dr. also said to relax that she has heard of some people reacting this way and told me to give it time to go away.