chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist, refers to two patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date the patients were vaccinated with doses of improperly stored GARDASIL 9 (which had a lot # of L016429 and an expiration date of 09-AUG-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 0.3C for 26 days and -11C for 5 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
09/21/21  The patient presents with Diabetic symptoms beginning last night. Pt suddenly began feeling sick beginning with increased thirst, generalized discomfort, nausea, vomiting, and SOB. Symptoms worsened today with increased discomfort and vomiting. Pt took her metformin yesterday but EMS states that her BGL was 560 PTA. Denies cough, nasal congestion, chest congestion, and fever. She had a negative COVID test yesterday. Associated symptoms: nausea, vomiting, shortness of breath, denies chest pain, denies abdominal pain, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
Pt relates she was sitting and bumped her knee on a metal table. She leaned forward and then everything went black. She was assisted to the floor with head and neck support maintained. The assistant that helped her, stated that she had her eyes open and was limp and also she had an episode of about 4 seconds of whole body shaking. Pt relates that all tests done in ER were negative and her vital signs were normal, including her temperature. She states that she felt light-headed when she came around and only complained of left deltoid soreness with palpation. Denies any history of seizures or past syncope. Dx'd at ER with vasovagal reaction.
Information has been received from a registered medical assistant concerning a 4 year old male who was vaccinated with VARIVAX (route not reported) on an unspecified date. Subsequently the patient developed chickenpox. The date of the onset of the chickenpox. No further information is available.
A report has been received from a Health Professional concerning a 6 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 22-Jan-2014. The patient experienced ADMINISTRATION OF EXPIRED DOSE which started on 22-Jan-2014. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious by the reporter.
Information has been received from a physician concerning a female believed to be 11 years old with no medical history and no drug allergies, who, "two weeks ago" on approximately 21-AUG-2007, was vaccinated with a dose of GARDASIL. Subsequently, after receiving the vaccination the patient was still at the office and became lightheaded, but did not faint. The patient was observe at the office for 15 minutes and then was "fine" and was sent home. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint); vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint)/prior instances of vasovagal reaction to getting a shot; This is a spontaneous report from a contactable consumer.  A 23-year-old female patient (reporter's daughter) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6202), via an unspecified route of administration on 26Feb2021 15:30 (at 23-years-old) at single dose (Left arm) for COVID-19 immunization. Facility type vaccine: Public Health Clinic facility.  Medical history included asthma and prior instances of vasovagal reaction to getting a shot. Known allergies included sulfa drugs, penicillin, and amoxicillin. Patient had no COVID prior vaccination. Patient is not pregnant. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC), clindamycin (manufacturer unknown), triamcinolone acetonide (manufacturer unknown), tretinoin (RETIN-A), and multivitamin. Within 5 minutes on 26Feb2021 (also reported to be 03:30 PM) of receiving the vaccination, she experienced a vasovagal reaction (i.e., dizziness, ringing in ears, feeling faint). She immediately laid on the floor and the symptoms resolved within 15 minutes. No treatment was given. Patient was not COVID tested post vaccination. The outcome of the events was recovered on 26Feb2021.
Hives on entire body - no place not covered with hives - treated initially with Benadryl at home without success and went to the ER on 10-20-09 at 8:30am  10/23/09 ED records received service date 10/20/09. Assessement: Urticaria. Patient presents with generalized hives.
lt deltoid immun w/Td given 9AUG97;3 days of soreness & swelling;on 3rd AM awoke w/redness, inc in size & now itchiness;applied 13AUg97 per CHN;front & back 8" long & 4" wide;
Patient went to bed two hours after vaccine administered.  Woke up next morning complained about fatigue during the day and sore arm. Showers in the PM next day. Mom notice small all over body rash after PM shower next day while rubbing his back before bedtime.  Rash noted on third night all over back noted rash travels to upper thighs.
the patient need about 3 people to help him walk; sore arm; feeling abnormal; chills; nausea; fever (101.7 F); energy and streng have not been fully regained; symptoms were like Guillain-Barre syndrome; This spontaneous report was received from a consumer via manufacturer and refers to an adult male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2021, the patient was vaccinated with a dose of influenza vaccine (FLUZONE) administered intramuscularly on the left deltoid (strength, dosage regimen, formulation, lot #, and expiry date were not provided); influenza vaccine (strength, dosage regimen, anatomical location, formulation, lot #, expiry date, and route of administration were not provided); and  covid-19 vaccine, administered (strength, formulation, lot #, expiry date, anatomical location, and route of administration were not provided). On an unknown date in July 2021 (also reported as "about a year ago"), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided). On 28-OCT-2021, the patient was vaccinated with a dose of varicella zoster vaccine (SHINGRIX) intramuscularly (strength, formulation, dosage regimen, lot #, anatomical location, and expiry date were not provided) all vaccines were administered as prophylaxis.  On 29-OCT-2021 (also reported as "following the administration of influenza vaccine [FLUZONE], pneumococcal vaccine, polyvalent [23-valent] [PNEUMOVAX23], varicella zoster vaccine [SHINGRIX], COVID-19 vaccine, and influenza vaccine"), the patient experienced chills, fever of 101.7 farenheit degree, nausea, a sore arm, and his energy and strengh had not been fully regained (asthenia), he was feeling abnormal, and needed about 3 people to help him walk (difficulty in walking). On the same date, the patient was hospitalized (conflicting information, also reported as "emergency room") at around 4:00 pm for all the events. On 29-OCT-2021, the patient was discharged from the hospital, at 9:30 pm. The reporter stated that Guillan-Barre syndrome had not been diagnosed, but he thinks that symptoms were like Guillain-Barre syndrome. The reported stated that the patient received the 1st and 2nd dose of COVID-19 vaccine but did not had any major reaction other than a sore arm. On an unspecified date, the patient underwent a scan that showed there were no sings of stroke. On an unknown date, a blood test was normal.  The outcome of the events chills, fever, nausea, feeling abnormal, and difficulty in walking was reported as resolved. At the time of the report, the outcome of the event asthenia was not resolved, and the outcome of the event pain in extremity was unknown.  The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  The reported considered that the event of difficulty in walking was disabling.  Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant.
8 1/2 x 12 1/2 cm arm of cellulitis on left proximal arm.
The patient was administered a Moderna COVID-19  booster dose that had surpassed the refrigeration expiration date by two days. Per our pharmacy, this Moderna COVID-19 vaccine (LOT #045L21A) expired on 4/6/2022 at 15:11. The patient received a booster dose on 4/8/2022 at 9:34 AM. No adverse reactions were documented after the patient was administered this vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown ages. On unknown dates the patients were intramuscular vaccinated with 0.8 ml or 0.7 ml doses of GARDASIL instead of the recommended 0.5 ml dose. No adverse effects reported. The patients had sought unspecified medical attention. Additional information is not expected.
Child had the chicken pox shot on 1/3/02 from previous Dr. Child had reaction on chickenpox.
Injection site pain; Redness; Swelling; Fever; Fatigue; Aches; Chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling), PYREXIA (Fever) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Aches) and CHILLS (Chills) outcome was unknown.            No treatment information was provided.
Patient stated he felt tachycardic post vaccination. Vitals were done HR was 119 BPM, rested and HR was 110 BPM, Family stated he has cardiac history, he felt better  and left with his family.
Neurological problems; Was imbalanced; Unable to walk; This is a spontaneous report from a contactable consumer (patient's daughter). A 79-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 2 at vaccination age of 79-year-old via an unspecified route of administration in the right arm on 20Mar2021 10:30 (Lot Number: EN6207) as dose 2, 0.3 ml single for covid-19 immunisation. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) on 27Feb2021 (LOT: EN6202) injection in the right arm at dose 1, 0.3 mL single at vaccination age of 79-year-old for COVID-19 Immunization. The patient medical history, family medical history and relevant Tests were none. The patient's concomitant medications were not reported. The patient did not receive other vaccination 4 weeks prior to the first administration date of the suspect vaccine. The reporter stated that she called with regards to the Pfizer vaccine that her father received two weeks within (Mar2021) having the second dose, he started to have neurological problems, he was imbalanced, and unable to walk. She added that he is in hospice and they don't think he's going to make it. She stated that she wanted to report just to let Pfizer know so maybe Pfizer can prepare someone else. The patient was first hospitalized from 28May2021 to 02Jun2021 and the patient came home on 02Jun2021 but went back to the hospital on 04Jun2021 to 05Jun2021 (second hospitalization). The third hospitalization was on Saturday (05Jun2021), he went to a rehabilitation center and was there until 14Jun2021. The reporter stated that they weren't allowed to see him for 10 days because of the COVID stuff and when they saw him on 14Jun2021, he had diminished drastically so he went back to the hospital. The daughter stated that he went right into the Palliative care unit. The adverse events resulted in emergency room and physician office visit. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning an 18 year old female who on 01-APR-2009 was vaccinated with a dose of GARDASIL (lot # 661766/0652X) and found she was pregnant one week later. The patient called the office. No adverse events reported. Follow-up information was received from the nurse indicating that this patient ended up having a "natural" miscarriage at 10 weeks gestation and followed up with her OB care provider. The patient did not have any complications, and according to the nurse, the obstetrician did not consider the spontaneous abortion to be related to the vaccine. No further information is available.
Patient is a 78 y.o. female patient of, DO with history of hypertension, hyperlipidemia, OSA, COPD, chronic respiratory failure on oxygen, hypothyroidism, DNR CCA as per nursing home documentations, who was brought by EMS from ECF for acute confusion, unable to provide meaningful history, last seen normal 7 PM last night, she was discovered to be confused and moaning incomprehensible words.    Acute metabolic encephalopathy Combination of hypercarbia, infection, rule out stroke ABG reviewed with hypercarbia.  With elevated baseline PCO2 in the high 60s. Continue BiPAP use at nighttime.   Evaluated by telestroke initial CT head negative. MRI brain without contrast. Aspirin 81 mg daily Lipitor 40 mg daily. PT OT SLP evaluation. Cleared for discharge per neurology Acute on chronic hypoxemic hypercarbic respiratory failure COPD with exacerbation OSA on CPAP CT chest normal lungs Albuterol MDI, Symbicort, dexamethasone Continue BiPAP use with naps and nighttime.   Sepsis, POA Sigmoid diverticulitis, acute, mild Urinary tract infection Urine culture with Proteus. Continue Zosyn Patient can continue Augmentin on discharge   Hypernatremia, likely hypovolemic On D5 water. Improved   Covid-19 Virus Infection Date of onset of symptoms: None Symptoms present on admission: Respiratory failure Date of covid positive test: May 14 Vaccination status: unvaccinated Imaging: CT lung Oxygen requirements on admission: BiPAP Current oxygen requirements: BiPAP Medical therapy: remdesivir and steroids Consultants following: Infectious disease Anticipated special isolation end date: May 24   Hypothyroidism, continue thyroxine, TSH elevated. Free T4 WNL. Increase levothyroxine to 125 mcg daily.   Hypertension, losartan on hold due to sepsis on admission.  Resume as needed.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037KZ0A and 041L20A.) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
see ADR narrative  Narrative: Event #1 Jul 5, 21 woke up with severe pain LEFT shoulder, upper arm, paralysis of LEFT shoulder; MRI 7/7; Neurosurg 7/11 brachial neuritis, sent to get EMG by neurologist; 7/20 diagnosed with brachial neuritis, sent to get EMG by neurologist; 7-20 diagnosed with brachial neuritis, told to get PT, pain meds. PT since August, still continuing; still has mild weakness, can now lift LEFT arm above shoulder. Event #2 May 10, 21 severe, sudden onset LEFT hip pain, bedridden, could not work, pain still continues LEFT hip, LEFT back of thigh. Patient is recovering but is not fully recovered.
Severe diarrhea and dry heaves about 22 hours after second Pfizer vaccine.  Lasted for approximately 3 hours.  Slowly gaining strength back 48 hours after shot.
After receiving the Moderna Booster on 11/3/2021, I developed hives on 11/14. I went to my family doctor on 11/16 and was diagnosed with hives. There has been no changes to my medicine, environment, food, or other variables that would prompt hives to develop.
wk of 20th skin began to itch;the following wk small bumps w/fluid appeared on arms, stomach, buttock & legs & foot;
Swollen lymph node in left arm pit, swollen clavicular left sided lymph node
Very sore arm - could not touch or lay on that side for 3 nights. Slight fatigue for 2 days. "Hot spots" on skin for 1 day, as if fever, though oral temperature was normal.
Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed . Please help me .  I have taken Tylenol
RN gave Varicella and MMR vaccines intra-muscular vs subcutaneous. Patient did not experience an adverse event after receiving the vaccine.
HCP ADMINISTERED 0.1ML OF  JANSSEN COVID-19 VACCINE AND  THEN REALIZED THAT IT SHOULD  HAVE BEEN 0.5ML SO ADMINISTERED  THE REMAINING 0.4ML WITHIN 30S TO  1 MINUTE AFTER 0.1ML DOSE; This spontaneous report received from a patient concerned a patient of unspecified age. 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: Unk) .5 ml, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced hcp administered 0.1ml of janssen covid-19 vaccine and then realized that it should have been 0.5ml so administered the remaining 0.4ml within 30s to 1 minute after 0.1ml dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hcp administered 0.1ml of janssen covid-19 vaccine and then realized that it should have been 0.5ml so administered the remaining 0.4ml within 30s to 1 minute after 0.1ml dose was not reported. This report was non-serious.
When I caught COVID-19 I had symptoms of a sinus infection. The first 10 days I had a cough. After the 2nd day of testing positive I called my doctor, and she prescribed me with PAXLOVID. I quarantined and wore a mask for 5 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included methotrexate. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, fever and chills. On an unknown date, the outcome of the injection site erythema, injection site pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had a little redness and soreness at the injection site and had chills and fever that lasted may be a day. This case has linked to case US2018GSK162661, reported by same reporter for same patient.
Patient was seen on Saturday 10/12/02 for red, swollen, warm to touch right thigh where immunization was administered on 10/10/02 IM right thigh and HIB left thigh IM in our office.
Vertigo, ear congestion, balance issues since 3 days post vaccine 1. Normal ENT exam, normal EKG and echocardiogram. Normal MRI. Vestibular hypofunction determined at vestibular physical therapy assessment.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153:
Hives; Skin blisters; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09May2021 at 07:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09May2021 at 21:30, the patient experienced hives and skin blisters. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and skin blisters was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.