chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash below injection site; Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash and injection site pain were unknown.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 54 or 55 years. The reporter stated that the patient developed injection site pain and a rash below the injection site. The reporter did not consent to follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: patient fell over and passed out a few minutes after administration, possible seizure occured. EMT services were called and patient declined to go with them.
Patient was hospitalized for 3 days.                       2nd dose of vaccine was 2/26/2021***
Within 24 hours I experienced severe itching on the lower left side of my back.  I asked my husband to take a look because I felt some small raised bumps and he thought it looked like Shingles (verified with internet photos).  I had an appointment with my primary care provider within 48 hours, showed it to her and she confirmed through a viral skin test that it was indeed Shingles.  She put me on Acyclovir, 800 mg tablets - 1 tablet by mouth, five times daily for 7 days.
Faint, decrease level of consciousness, ringing in left ear, numbness of left side of body, decrease hearing in left ear and headaches
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Follow-up received 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
PATIENT RECEIVED VACCINE AT 9:04AM. AT 9:37AM PATIENT RETURNED TO THE COUNTER WITH A RED RASH ON NECK AND CHEST. PATIENT DENIED BREATHING DIFFICULTY AT THE TIME. PATIENT WAS GIVEN 50MG OF DIPHENHYDRAMINE AT 9:38AM. AT 9:44AM PATIENT STATED TONGUE FELT NUMB AND TINGLY AND WAS PROGRESSIVELY GETTING WORSE. PATIENT WAS TAKEN TO IMMUNIZATION AREA AND PHARMACIST ADMINISTERED 0.3MG EPINEPHRINE IM. PATIENT WAS SEATED AND GIVEN WATER. PATIENT WAS MONITORED FOR ANOTHER 20 MINUTES BEFORE SHE FELT SHE WAS FEELING BETTER.
heaviness in both legs; unstable feeling in both legs; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (heaviness in both legs) and FEELING ABNORMAL (unstable feeling in both legs) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Shoulder).    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (heaviness in both legs) and FEELING ABNORMAL (unstable feeling in both legs). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at a dose of 800 mg. At the time of the report, LIMB DISCOMFORT (heaviness in both legs) and FEELING ABNORMAL (unstable feeling in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Nausea, lethargy, headache, low-grade fever (99.7F), chills
Pregnancy Due Date: 30Oct2022; Psoriasis flair up all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: FJ11989) at the age of 31 years, in right arm for covid-19 immunisation. Date of last menstrual period: 23Jan2022. The patient was 17 weeks pregnant at the time of exposure to BNT162b2. The patient was 19 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Oct2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PSORIASIS (non-serious) with onset 25May2022, outcome "recovered" (2022), described as "Psoriasis flair up all over body"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Pregnancy Due Date: 30Oct2022".  Additional information: The patient had no known allergies to medications, food, or other products. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
red, hot, swollen arm, with a bump and with rash under spot where injection was given.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report was received from a pharmacist, via a company representative, referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. The reporter stated that the patient had recurring shingles, since an unknown date. At the time of reporting, the outcome of recurring shingles was unknown. The reporter did not assess the relationship between ZOSTAVAX and the recurring shingles. Additional information has been requested.
Chills, fatigue. fever(100.9), bodyaches.  Redness, warmth, tenderness, itching, tingling and numbness in right arm and fingers.
Inflammation, swelling, sores first few days. Difficulty moving arm, lack of full range of motion. Unable to sleep on left arm.  Deep, intense pain in arm and shoulder joint. Pain growing more intense.
pt recvd vax; flu like feeling & arthralgia beginning 20mar94 4 days p/ vax;devel hives 25mar94 & angiodema of face & lips on 26mar94;tx 26mar94 by MD w/ adrenalin,solu-medrol,IV,dph;sent home on seldane & prednisone;recovered 28mar94
Client received vaccine at 10:42am and was sitting in clinic to be observed for 15 minutes. Client asked nurse to come over because he was feeling lightheaded and was sweaty. RN noticed client was very pale and diaphoretic. Client began to pass out and RN assisted him to the floor. Clients legs were elevated on a chair, cold washcloth placed on his head, and pillow placed under his head. Client opened his eyes about to 10-15 seconds later. Clients heart rate was 62 and blood pressure 80/52 . Offered client some juice and crackers and had him to continue to lay down until he started feeling better.  After 15 minutes rechecked blood pressure 120/80 assisted client to sitting position then gradually helped him to stand and helped him sit in chair. Client ate two peanut butter crackers and had some juice, Client was observed for another 15 minutes. stated he was feeling better and was ready to go home. Nurse walked him to the door. Client called when he made it home and stated he was feeling better and was going to eat some lunch.  Another RN called Client on 12/7/2021 at 9:30am to check on him. Client stated he had some muscle aches, soreness and chills but he had that with his two first COVID shots. Client s tated he made an appointment with his doctoor on 12/13/2021 to follow up.
Following day pt noticed redness, had temp of 99 orally, applied ice; Next day red, hard, swollen & throbbing; kernel under arm; To ER told to apply heat & continue ATB;
Patient began to feel flushed and felt lips swelling.  Proceeded to the ER 30 min after injection. Onset of warm feeling, itching, fatigue, some mild edema of her upper lip but no sublingual edema, no posterior oropharyngeal edema,  no stridor, no neck swelling, no evidence of airway compromise.  scratchy voice, and flushed appearance. Hypertension IM Epinephrine accidentally give IV - patient was monitored after, IV fluid bolus, Benadryl, Solu-Medral. Discharged with Loratadine 10mg daily for 14 days and and Epinephrine 0.12mg Injectable subcutaneous once.
This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1706USA011670: US-00507513-1706USA011307: US-00507513-1706USA011671: US-00507513-1706USA011668:
Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage; headache/pounding headaches; This spontaneous case was reported by a patient and describes the occurrence of OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) and HEADACHE (headache/pounding headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Mar-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) and HEADACHE (headache/pounding headaches). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at a dose of 200 milligram. At the time of the report, OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) outcome was unknown and HEADACHE (headache/pounding headaches) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.         Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Patient demographics, dose details, vaccination facility details added. Event updated. On 19-Jul-2021: Follow up document  received on 19-JUL-2021 .Updated the event( Headache) is still ongoing.
Afternoon after injection: severe internal itching around the injection site that proceeded through the evening.  Morning after injection: extreme fatigue, Dizziness upon waking and standing up. Dizziness has persisted throughout following day.  Mild headache,  extreme muscle aches, skin sensitivity when touched,  stiffness in all joints and limbs, red and very tender upper arm around injection site. Neck and shoulder pain/tenderness to touch that extends into the rib cage on right side.
Fever, chills, hot flashes, sweats, nausea, headache, fatigue
Major outpatient eye surgery which called for a bubble in eye; Detached retina; Arm was hard and rashy; Felt weak; Achy; A spontaneous report was received from a consumer concerning herself a 49 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness/asthenia, achy/pain, arm was hard and rashy/vaccination site rash, detached retina, major outpatient eye surgery which called for a bubble in eye/eye abnormality NOS.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28Feb2021, prior to the onset of events the patient received first dose of the two planned doses of mRNA-1273 (Batch/Lot No: 014M20A) for prophylaxis of COVID-19 infection.  On 02Mar2021, patient experienced felt weak and achy. On 05Mar2021 she reported that her arm was hard and rashy. On 8Mar2021, she had a detached retina and on 09Mar2021, the patient had major outpatient eye surgery which called for a bubble in eye which was still there. The event Retinal Detachment was considered as medically significant. Treatment information included Prednisone and Atrione for events Detached retina and Major outpatient eye surgery which called for a bubble in eye.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, Felt weak, achy, arm was hard and rashy was unknown at the time of this report. The outcome of the events Arm was hard and rashy was recovered on an unknown date, Major outpatient eye surgery which called for a bubble in eye and Detached retina were recovered on 09Mar2021 at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4:06PM Nauseated then dizzy c/o burning in her spine. BP: 62/38, HR: 140  Pt stated "she was seeing black spots."  4:20PM  BP 84/76, HR 74 EMS called and they left.  Pt drank 2 small bottles of water and her BP improved.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 78-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 14-OCT-2010, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No informaton about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
This is a 64y.o. female with a past medical history of hyperlipidemia, hypertension presenting to the emergency department today with shortness of breath and chest pain. Patient states that on Thursday the 25th she tested positive for Covid here in the emergency department. Patient stated that the emergency department was busy in full she thought that she could get well at home by continuing supportive care at home. Starting today the 30th patient stated that she began to feel increasingly short of breath and experiencing intermittent sharp chest pains. Patient describes the pains as being in the center of her chest and lasting only a few seconds. Patient is also endorsing a nonproductive cough that has recently worsened today. Patient has been taking Tylenol and Motrin at home to mitigate her fever. Patient states that she had a fever of 101 earlier today. Patient is also endorsing chills. Patient states that she is nauseous and has lost her taste and smell. Patient has been able to eat but less than her normal appetite. Patient is able to drink fluids. Patient currently denying headache, sore throat, abdominal pain, vomiting, supination, diarrhea, change in her urinary habits, and increased lower extremity swelling. Patient does note she has chronic lymphedema of bilateral lower extremities but it is mild. Patient has been vaccinated against Covid.   Patient was evaluated in the emergency department and was found to have a hemoglobin of 11.6, a d-dimer of 605, and a calcium of 8.1. Patient was requiring 2 L of oxygen nasal cannula to maintain saturations in the mid 90s. Patient also had chest x-ray done that showed hazy bibasilar airspace disease.
pt recvd vax 17OCT94 & later in evening began exp weakness & severe pain in upper body muscles;(chest, back, neck);MD visit 25OCT;APAP given;CBC results pending;dx myositis & post viral synd
did not receive the full 0.5mL.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received Herpes zoster (Shingrix) (batch number 259GZ, expiry date 15-MAY-2025) for prophylaxis.   On 08-AUG-2023, the patient received the 2nd dose of Shingrix. On 08-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: did not receive the full 0.5mL.). The outcome of the inappropriate dose of vaccine administered was unknown.   Additional Information: Receipt Date: 09-AUG-2023 The pharmacist reported that a patient moved away during administration of their second dose of Shingrix and did not receive the full 0.5mL, which led to inappropriate dose of vaccine administered. The reporter was unable to say how much of the product the patient received. The reporter did not wish to share the patient's initials and date of birth without speaking to her first. No additional information provided. The reporter consented to follow up.
Right arm swelling, warmth, erythema that developed within hours after vaccinations (IPV, MMR, DtaP) delivered to same arm.  Treatment prior to arrival at clinic by parent: none, treatment after presentation to clinic, anti inflammatory, cold compress, return to clinic for re evaluate.
Contracted varicella (Dx on 11/15/02) received Varivax 7/28/98.