chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient became severely SOB 1 hour after receiving J&J vaccine. Called 911 & brought to ED in severe respiratory distress on CPAP changed to bipap in ED. Diagnosed with Flash Pulmonary Edema, malignant hypertension, lactic acidosis, leukocytosis
DVT of left popliteal vein per Venous US 4/14/21
Pt experienced hives beginning on left arm site to neck, trunk, and face with nausea and vomiting.
facial numbness and weakness (left-side): jawline, chin, lips; tongue numbess; hand numbess (left)
Hospitalized Due to Covid-19 vaccine reaction. Hospitalized at Community Hospital (PRIVATE).
Syncope x 2, pallor, and lethargy 16 hours post administration of influenza vaccine.  CBC and comprehensive metabolic panel obtained, results normal, treated with IV hydration x 2 hours and monitored closely in clinic, condition stable, discharged home.
Information has been downloaded from Regulatory Authority (US-CHIRONMA-PHHY2014US006398). Information has been received from a consumer referring to a 5 year old female patient. Information of concomitant therapy, concurrent condition and medical history was not reported. On 14-NOV-2013, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); influenza virus vaccine (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); diphtheria toxoid, pertussis vaccine (unspecified); poliovirus vaccine inactivated (unspecified), tetanus toxoid (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) and varicella virus vaccine live (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) for immunisation. On 14-NOV-2013, the patient experienced blood pressure low, brain hurt, cry, disoriented, fainted, pale, unresponsive and weak. The outcome of the events was reported as recovered. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (reported as reasonable possibility). The reporter considered the events of blood pressure low, brain hurt, disoriented, fainted, pale and unresponsive were related to influenza virus vaccine (unspecified). All the events were determined to be medically significant by the reporter.
On 10/23/2001 the patient complained of dizziness and nausea approximately 20 minutes post vax until the patient retired for the evening.
Itchy, hot rash and skin rashes from shoulder to elbow. Still today at four days, it is itchy, but the rash and heat have reduced
Just sore when touched where it the shot was.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received RSV vaccine and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: Just sore when touched where it the shot was.).  The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to RSV vaccine.     It was unknown if the company considered the injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that no problem with the shot, just sore when touched where it the shot was and got the flu shot same time. It was unknown if the reporter considered the injection site pain to be related to Flu vaccine.  Follow up was not possible, as no contact details were available.
12 hours after injection I became very ill with vomiting, diarrhea, incontinance, severe chills, fever, pain in arm radiating up to the left side of my face. The pain and lightheadedness continued for 48 hours. I tried to take pepto and ibuprofen but couldn't keep it down.
About 8 hours after vaccine my left arm became very sore. It hurt to move it or touch it in the slightest. I ran fever that night and all the next day. Highest temp taken was 101.6
Pt exp non-response p/a series of 3 doses of Engerix-B given 16APR90, 14MAY90, & 9NOV90; 2 additional doses of vax given on 26FEB91 & 1APR91 & pt seroconverted;
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL 9 lot # N000326 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA013474: US-009507513-1708USA011923: US-009507513-1708USA013473.
No additonal AE's a; A nurse reported that a dose of PROQUAD was administered to a sixteen year old patient indavertently.  No additonal AE's and no PQC's were reported.; This spontaneous report was received from a nurse and referred to a 16-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 07-JAN-2023, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) subcutaneous injection (1 DS X 10 vials) (1 dosage form, lot #W029548, expiration date: 14-MAR-2024; strength, anatomical location and route of administration were not provided) for prophylaxis inadvertently (product administered to patient of inappropriate age). No additional (adverse events) AE's were reported (no adverse event).
BODY ACHE; FELT FLEXED; SUPER FLUEY AND OFFAL; CHILLS; FEVER; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201821A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced felt flexed. On 07-APR-2021, the subject experienced super fluey and offal. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, felt flexed, super fluey and offal, chills, and fever on 09-APR-2021. This report was non-serious.
Pt. states that after receiving the 1st dose of Phizer 03/16/2021, started experiencing symptoms of Tachycardia, loose bowels, and migraines. Symptoms continued for 8 days (since 1x monthly), Migraines continue 03/18/2021 Primary communications with (PA). 03/19/2021 Urgent Care visit tachycardia, chills, fatigue, and loose bowels : Negative Covid-19 Pulse 102, EKG, Urine Test. Urgent Care visit 04/19/2021 Heart Palpations, increased urination. 04/29/2021 Urgent Care visit (Migraine) with pain in right eye and flashing "strobe-like" behind eye, MRI ran (Ocular Migraine). Still continuing to experience symptoms.
Case number PHEH2014US003969, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 with follow-up received on 01 APR 2014. This report refers to a 17-year-old male patient. Past medical history included congenital heart defect. He was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: 004011A/006001A and expiry date: JUN 2014) at 0.5 ml intramuscularly on 14 JAN 2014. This was the initial application of FLUCELVAX. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).    Follow-up received from the pharmacist on 01 APR 2014: Updated medical history and information on initial application of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication  as "drug used in unapproved population".
Arm and leg weakness beginning in April of 2005. Hospitalized for GBS like illness. April 21-May  14, 2005. Hospitalized May 14-May 19, 2005 and Rehab hospital May 19-June 14, 2005. Is wheelchair bound and is unable to lift arms. Discharge summaries state myosis, myopathy, atrial fibrulation. msv
Hives, itching, burning, fatigue, chills, nausea, low grade fever
Erythematous, blanching rash on face, trunk, and arm appeared w/I 24 hours of vaccination. Well appearing otherwise.
Large red area with induration 40mm x 40mm. Blistering noted at center of injection site. Pt c/o fever of 99.0-100.2 2 days after the injection and headache. Used MOTRIN q 8 hours and ice to area.
Patient experienced itching and swelling following COVID-19 vaccination. Noted 5/12/2023
Moderna COVID-19 Vaccine EUA.  Client was vaccinated and proceeded to the monitoring area. Several minutes after sitting down in the monitoring area, she passed out and fell onto the floor. The client responded immediately after being repositioned. She was very pale and stated that she was having her menses. She received juice and water. Her vital were taken--BP 124/70, pulse in the 70s, pulse oximeter was 100%, no elevated temperature. EMS was called and arrived within 3 minutes of being called, before a second set of vitals could be taken.
lymph node clavicle swollen; lymph node clavicle tender to touch; rash on left arm; chills; fever; tiredness; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node clavicle swollen), LYMPH NODE PAIN (lymph node clavicle tender to touch), VACCINATION SITE RASH (rash on left arm), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Lymphoma (Previous history of mother with lymphoma). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 03-Jul-2014 to an unknown date for an unknown indication.   On 12-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (body ache). On 13-Feb-2021 at 5:00 PM, the patient experienced LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch). On 10-Feb-2021, HEADACHE (headache) and MYALGIA (body ache) had resolved. On 11-Feb-2021, VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever) and FATIGUE (tiredness) had resolved. On 03-Mar-2021, LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch) had resolved.            It was reported that the patient took 2 Moultrie in Feb 2021, two days before the initial report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Adverse drug reaction safety information received and patient sent pictures via email.
Migraine, nausea, diarrhea lasting 3 days.  rest, fluids.
Information has been received from a nurse concerning a 10 month old patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Merck) (lot# unspecified). The nurse mentioned that on 04-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
immediately felt light headed HR 77, BP 108/64 SaO299% stated "I feel a migraine starting'
bells palsy; facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date (if covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient experienced Bell's palsy and facial paralysis on 10Aug2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included treatment with an unspecified medicine. The patient was not tested post vaccination. The patient did not recover from the events.   No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830.  By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
PCR test positive; Rapid test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Rapid test positive) and SARS-COV-2 TEST POSITIVE (PCR test positive) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Rapid test positive). On 14-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (PCR test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Rapid test positive) and SARS-COV-2 TEST POSITIVE (PCR test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: positive Positive. On 14-Jul-2021, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Preferred method for safety follow up was phone.
had moderna covid vaccine yesterday at hospital 9 am states nurse was aware she had covid in december but talked to nurse and who reportedly talked ot cdc personnel who gave approval to give moderna vaccine saying if patient felt ok then ok to receive so was given following vaccine had arm pain and this lasted several hours last nite had trouble sleeping and woke up disoriented body hurts felt chills diarrhea and then on way to work vomited multiple times bilious now nausea no rash no fever but + chills and feels out of it right arm itchy red tender has headache confusion but denies sob advised will do Vaers and hold on second dose right now and work note   Vaccine was given at Hospital on 1-12
Patient experienced fever, which has been reported. But she also has a strange and painful red streak going down her arm that has not improved. The fever improved, but the streak has not.
1, By 9pm, my right arm from elbow to shoulder was swollen and extreme pain to touch. By 11pm, I laid to sleep, and my arm was now just in extreme pain without touch. It continued the entire night. At 3am, I took 4 Advil 225mg each. By 5am I was able to fall asleep. I woke at 9am and the swelling and pain had gone from 9 to a 3 on scale of 1-10. I decided to go to work that day and take more Advil as needed. 2, injection site on right arm, still pink 3/16? circle on 5/20/21, three weeks later.
Noticed red rash 1X2 in at injection site on 1/28 1/29 color had faded, rash doubled in size 1/30 separate red blotches and streaks on arm and chest photos taken each day
Initial report received from a consumer on 03 November 2008. A 52-year-old female patient received a dose of FLUZONE SV 2008-2009 (lot number, route administration and number of previous doses not reported) to the left deltoid on 15 October 2008 and that same day, she developed arm soreness and redness that lasted approximately four days. On 23 October 2008, the patient received a dose of PNEUMOVAX (lot number, route of administration and number of previous doses not reported) to the right deltoid. Within 24 hours, the patient developed a fever of 102 degrees Fahrenheit, her arm became beet red, the veins in her chest were pronounced and the arm site became as hard as a rock. The patient also complained of muscle weakness which, at the time of the report, was almost completely resolved. Patient outcome was reported as 'not recovered'. Follow up information was received on 26 November 2008 from a health care professional. The patient received a dose of Fluzone SV 2008-2009 (lot number U2839AA) to the left deltoid on 15 October 2008. The number of previous doses received was reported as multiple. No further information was provided. Follow up information received on 02 January 2009 from a health care professional. The abbreviation for concomitant medication EES was confirmed to be erythromycin. Per the reporter, they did not see the patient after she received the Fluzone SV 2008-2009. Recovery status was not provided. No further information is expected.
17-years-old received the 1st dose of  Moderna COVID 19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment drugs were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021 and does not contain any new information.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Shingles after dose 1. Valacyclovir cleared it   Viral Cold sores dose 2. Valacyclovir cleared it
Intermittent flushing in ears, fingers and toes for 3-4 hours after shot shooting pain from L elbow to L wrist and knuckles that lasted about a minute
Initial report received from a healthcare professional on 09 November 2013. A 60-year-old male patient had received a dose of FLUZONE Intradermal, (batch number, dose number, route and site of administration not reported) on 29 October 2013. The patient's medical history and concomitant medications were not reported. On 31 October 2013, the patient came back into the office to have the local reaction looked at. The patient had a large local reaction that was blistering and had to be drained. The patient had a high fever, vomiting, and became unconscious while in the office. The patient was then admitted to the hospital. The patient is now doing better, but still has a lump where the shot was administered. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Upon second medical examination of the case on 19 December 2013 it was found that the Clock Start Date of the case was wrongly captured and was thus changed to 12 December 2013.
Arm swelling; Arm hard at touch; Arm  rash; Arm hot at the touch; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site swelling,induration,hot to touch and rash.  The patient's medical history was not reported. Concomitant medication was not reported.  13-FEB-2021,Prior to the onset of the events, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.  Patient started experiencing arm swelling and hard at the touch,arm warm at the touch.  No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events is Unknown.