chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist, as part of the rebate patient support program, refers to a female patient of unknown age with hypertension, thyroid issues and gastrointestinal (GI) tract malfunction. At the time of this report the patient had no known allergies. On  07-NOV-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K010648, expiration date 30-OCT-2015, 0.65 ml, subcutaneous in the left arm (dose number was unspecified). Concomitant therapies were unspecified (also reported as "nothing immunosuppressive"). On an unknown date in 2014 (a couple days ago), the patient experienced red spots on her skin, on her legs, stomach, arms and head. The reporter stated that had not observed these red spots. The reporter also stated that a phone call from the patient's son was received, reporting that the patient had been itching and had low grade fever. Treatments given for the adverse events were unspecified. The patient sought medical attention by calling physician but no one had returned the phone call. The pharmacist did not know of the patient developing shingles. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
78 Y/O FEMALE C/O NUMBNESS/TINGLING TO LEFT HAND. NO OTHER COMPLAIINTS PT MONITORED BY EMS UNTIL 10:45 A.M, PT STATED SYMPTOMS STARTED TO SUBSIDE. PT THEN CLEARED  ADVISED IF SYMPTOMS RETURN TO SEEK MEDICAL ATTENTION PER EMS.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Bad headache; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the right arm on 25Mar2021 at 09:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included uterine cancer (tumor removed successfully with hysterectomy), chronic pain (back, both knees)-need surgeries and other orthopedic issues. The patient had unspecified known allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 22:00, the patient experienced bad headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bad headache was resolved on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
full body rash; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) intramuscular, administered in Arm Left on 24Feb2021 13:30 (at the age of 33-years-old) as DOSE 2, SINGE for COVID-19 immunization. Medical history included diabetes mellitus, blood cholesterol increased, blood pressure increased from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), empagliflozin (JARDIANCE), fluoxetine (FLUOXETINE), lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), omeprazole (OMEPRAZOLE) taken for an unspecified indication. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) intramuscular, administered in Arm Left on 29Jan2021 13:30 (at the age of 33-years-old) as DOSE 1, SINGE for COVID-19 immunization. The patient experienced full body rash 4 days after the vaccine on 28Feb2021 22:00. AE resulted in emergency room/department or urgent care visit. Patient had received treatment for adverse event with cotisone shot and Zyrtec. Rash would not resolved with a cortisone shot. Benedryl helped somewhat. Since the vaccination, patient has not been tested for COVID-19. The outcome of event was recovered on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of intussusception in a infant male patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, several days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional information received: Sales Representative called into Medical Information to report that a male infant patient experienced intussusception after receiving a dose of ROTARIX. The patient was hospitalized and the HCP stated, "He's fine". This was all the information that the sales representative was given. She did not have the lot number, expiration date, vaccination date, date of onset of intussusception, etc.
Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Brain Fog; Toe Hematoma; Fatigue; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 08:30 (Lot number: EN6204) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), BACK PAIN (non-serious), CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "Inflammatory Sporadic pain-back, chest hand"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Brain Fog"; HAEMATOMA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Toe Hematoma"; FATIGUE (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Shortness of breath". The events "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "brain fog", "toe hematoma", "fatigue" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, back pain, chest pain, pain in extremity, feeling abnormal, haematoma, fatigue, dyspnoea.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
16MAR94 woke w/sore rt deltoid & erythema & achy APAP & warm moist packs for comfort; 18MAR94 9cm erythema @ site of Td booster warm packs; 21MAR resolved no erythema or induration;
patient was administered wrong vaccine/ no AE; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician.  This case involves an adult patient (unknown age and gender) who received wrong INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP] with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "She ordered Fluzone standard dose & received Fluzone High Dose. Dr then mentioned that she gave Fluzone High Dose to 2 separate patients (both 15 months of age) before realizing it was the wrong vaccine".  It was a case of actual medication error due Wrong vaccine administered (latency was on the same day).  It is unknown if the patient experienced any additional symptoms/events.  At the time of reporting, patient had no adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on batch number for this case.
Administered expired dose; Adult expired dose to pediatric patient; Adult expired dose to pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B adult) (batch number L9539, expiry date 7th December 2021) for prophylaxis.   On 23rd December 2021, the patient received Engerix B adult. On 23rd December 2021, unknown after receiving Engerix B adult, the patient experienced expired vaccine used, overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used, overdose and inappropriate age at vaccine administration were unknown.  Additional details were reported as follows:                 The clinical coordinator administered an expired adult dose of Engerix-B to a pediatric patient, which led to overdose, inappropriate age at vaccine administered and expired vaccine administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021262290:Same reporter, deleted case
Fever up to 102.2 on 9/21/ and 9/22 severe chest pains on night of 9/22, accompanied by excessive belching lightheadedness until 9/30 still belching but somewhat better with Pepcid since 9/27
HIVES ON BILATERAL UPPER AND LOWER EXTREMITIES, CHEST, AND BACK
Administered fluarix instead of boostrix. No adverse effects. Pt had inteded to receive both vaccines regardless so he was ok with getting it.
Information has been received from a registered nurse concerning a 20 month old white female pt with an ear infection and no past medical history and no known drug allergies who on 15Jul2002 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 09Apr2003 the patient developed general malaise. On 10Apr2003 the patient developed chicken pox, also described as a "full blown chickenpox-like rash" and had a fever. Unspecified medical attention was sought. Follow up information indicated that the patient's two older sisters had chickenpox starting on 24Mar2004 and 31Mar2003, respectively. The patient broke out with a rash on 10Apr2003, and the mother was worried that she had the chickenpox also. However the rash was later determined to be an allergic reaction to amoxicillin, which the patient started on 01Apr2003 for an ear infection. The outcome was reported as recovered. Information was received which pertained to events which occurred approximately 10 months after vaccination with varicella virus vaccine live. This information contained the following adverse experiences: allergic reaction to amoxicillin. (10Apr2003). The nurse also reported that two other siblings developed a mild case of chickenpox and developed a mild case of chickenpox and strep throat. Additional information has been requested.
Seen in office 2/22/04 with rash which was diagnosed by Dr as atypical varicella. Had 10 lesions scattered on torso and neck pink papules to pustules. Pt seen two times prior to this on 2/15/04 and 2/17/04 with nasal congestion and cough. Temp 99. Put on amoxicillin on 2/17/04 for nasopharyngitis/ bacterial rhinitis.
Left deltoid swollen, red, warm to touch. Pt states swollen nodes in axilla.
This spontaneous report was received from a Medical Assistant, refers to an unknown number of patients that may have been vaccinated, on unknown dates, with a dose of VAQTA (lot number and expiration date not reported) after incorrect temperature exposure. The medical assistant stated that VAQTA was exposed to 28.4 F for 10 minutes. Temperature conditions unsupported. No adverse effects reported. Additional information has been requested.
MOM WAS WITH PT INSIDE IMZ BOOTH. HE RECEIVED BOTH VACCINES. PT WAS NERVOUS AND MOM HELPED TO CALM HIM DOWN. HIS MOTHER ASKED HIM TO GO TO HIS FATHER. HIS FATHER WAS STANDING OUTSIDE THE IMZ BOOTHE.  HE  WALKED OVER TO HIS FATHER AFTER IMZ. I WAS THEN ABOUT TO GIVE HIS MOM AN IMZ ABOUT A MINUTE LATER WHEN I HEARD A COMMOTION OUTSIDE THE IMZ BOOTH. PT WAS LAYING ON THE FLOOR TRYING TO GET UP. HIS FATHER WAS KNEELING BESIDE HIM TELLING HIM TO STAY ON THE FLOOR. HIS FATHER SAID HE FAINTED. HE ASKED FOR SOMETHING WITH SUGAR. I GAVE THE FATHER A ROOT BEER SODA AND A PACKET OF YOUGURT.  THE FATHER KEPT THE PT ON THE FLOOR FOR ABOUT 10 MINS. HE HAD HIM DRINK SOME OF THE SODA AND CONSUME SOME OF THE YUOGURT.
1) Numbness in Fingers, then arms; weakness in legs and clumsy gait, increasing in severity. 2) Oleacron Bursitis; arthritis 3) Blood in urine 1) Diagnosed 5/2022 as severe cervical spinal stenosis
The day after my vaccine, the lymph nodes in my left armpit got really swollen and painful. It radiated down my side and into the left breast area. It hurts just sitting around or trying to move at all. I couldn't teach any of my fitness classes for 2 days. I took Tylenol, and Celebrex and it did not really do anything. I was having a hard time sleeping. I texted my physician and sent her pictures of the swelling. I also took some pain meds left over from a mouth surgery. We agreed to just keep monitoring it, and it got worse I should come in for a visit. Today 10/28/2021 it is still swollen but the pain is about half of what it's been the two previous days. I was able to teach classes today.
Attending Physician: (Privacy), DO;*     Date of Admission: 2/15/2022   Chief Complaint:  unresponsive   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 62y.o. male  presents to the ED on 02/15/22 via EMS for evaluation after he was found outside on his driveway for up to 3 hours.   per EMS told his mother that he "wanted to die" this afternoon and proceeded to drink a fifth of alcohol.  Patient states that he has no suicidal ideations at this time.  He states that he meant that he felt like he was going to die but had no intentions.  Patient states that he was supposed to have been implants put in for his hepatocellular carcinoma on 2/17/2022.  He was feeling emotionally stressed from his diagnosis of cancer which triggered his alcoholic binge.  In the ED, pt was hypertensive, tachycardic, hypothermic and hypoxic with improvement on 2LNC. Lactic acid 7.5, 3.9, 3.4. Troponin 0.05, 0.07, 0.09. ALP 469, AST 118, ALT 63. Ammonia 115. Lipase 166. Bili direct 1.3, bili total 2. WBC 12.8. Covid detected. UA negative for infection. CT cervical spine - 1. No evidence of cervical spine fracture as visualized. 2. Mild cervical spondylosis. CT facial - No evidence for acute facial bone fracture. CT trauma head/brain - 1. No acute intracranial process. 2. Nonspecific white matter changes, this most commonly relates to chronic microangiopathy. ECG - a-fib w RVR rate 149 with nonspecific ST/T. Chest xray - No pneumothorax or pleural effusion.  No focal consolidation. The cardiomediastinal silhouette is stable. Pelvis xray - Single AP view the pelvis was obtained. No acute fracture dislocation. Degenerative changes of the hips.  He is on a Cardizem drip for A. fib with RVR.
Patient developed fever (101.6 degrees), chills and aches about eight hours after injection.  He could not eat for the next 24 hours because of nausea and malaise.  On 9-21 he started getting bad headaches especially when he moved.  On 9-22 he developed a runny nose and red, watery eyes.  The symptoms have not yet subsided.
Pt was seen about 5 days after Zoster vaccine with redness and swelling of right deltoid. Used ibuprofen, cold packs, getting progressively worse. Rx'ed BACTRIM to treat. DS 1 tab BID x 10 days.
This spontaneous report was received from a pharmacist and refers to a 58 year old male patient. No information regarding the patients pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 28-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiration date 13-OCT-2016 (strength, dose and route of administration were not provided). On 30-OCT-2015 (reported as "for 2 days afterwards"), the patient experienced erythema and swelling at the injection site. The patient sought treatment from an unspecified physician on an unspecified date in 2015 and was prescribed KEFLEX. The patient sought medical attention via visiting the physician. The outcome of the events (the patient's present status) was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Rec'd call from pts daughter from home to report that pt started with chills/tremors & pain-redness-warmth to Lt arm injection site @ approx 130pm. Instructed to report to Hospital ER for prompt MD care.
Diarrhea; Achy; Throwing up all day; Fever; Chills on and off; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the arm left on 29Mar2021 at 09:30 (inappropriate schedule of vaccine administered) (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included interstitial cystitis. The patient never had any allergy to medication, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the arm left on 11Mar2021 at 01:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that, she was fine on the first day till 01:00, eleven hours after the vaccination (as reported- discrepancy). On 30Mar2021 at 01:00, she threw up all day, fever of 100 (unspecified units), and had chills on and off. On 31Mar2021, the patient still felt like she wanted to throw up, she still had chills and felt achy. On 01Apr2021 at 02:00, the patient experienced diarrhea and still felt like she wanted to throw up. The adverse events did not result in a doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events felt like throwing up, fever, chills, achy and diarrhea were not resolved at the time of this report. The clinical outcome of the event inappropriate schedule of vaccine was unknown at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
pt rcvd vax; concomitant medication propranolol HC1 (inderal) & interferon; pt exp'd low grade fever & aches;
Lost hearing in right ear approximately 29 hours after the 2nd vaccination.  After 1 week, I visited audiologist for hearing tests.  Results of the test showed Conductive Hearing Loss in right ear.  3 days following test results, visited ENT physician and they concluded that there was fluid in the middle ear leading to Conductive Hearing Loss.  They prescribed a steroid, antibiotic, and Flonase.  I just started taking the meds and there is no sign of recovery to date.
Spoke to Mom about pt.'s immunization reaction. Pt. received Dtap/IPV/HIB, Hep B, and Rotavirus at 9:30 AM on 10/11. Mom reported that she first noticed pt.'s fever around 7:30 PM on 10/11, temperature of 101.7 F. Mom went work and Grandma was watching pt., when about 30 minutes she was unresponsive. Grandma reported that her head was tilted back, her eyes rolled back, and unresponsive. The timing of this episode is unclear because Grandma had stepped away for about a minute and realized this once coming back.  Mom reported they then took pt. to Urgent Care where she appeared exhausted, with droopy eyes, and had a temp of 100.7 F. Mom stated that they administered Tylenol and advised her to continue the Tylenol for the next 24 hours. Later that night pt.'s fever broke. Mom stated that the next morning, 10/12, pt. appeared to be behaving normally. She since has not had any symptoms. Mom reports no concerns, she has been feeding well and has plenty of wet diapers.
Mom states he was seen by an [urgent care MD] and Dx'd with chicken pox. She claims that he has pox all over his body. Mom called the office 3/25/03 at 15:27.