chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin looked shriveled; skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny; upper chest (right below the neck) became red and slightly itchy; upper chest (right below the neck) became red; could barely lift her arm; swollen arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and MOVEMENT DISORDER (could barely lift her arm). On 09-Jan-2021, the patient experienced PRURITUS (upper chest (right below the neck) became red and slightly itchy) and ERYTHEMA (upper chest (right below the neck) became red). On 12-Jan-2021, the patient experienced SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny). At the time of the report, PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled), RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) and MOVEMENT DISORDER (could barely lift her arm) outcome was unknown. Not Provided      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.   Treatment information include calamin lotion.  . 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.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to FLUARIX TETRA. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that the patient had a Guillain-Barre reaction to a flu shot. Flu shot was from unknown manufacturer.
next day left arm was swollen, red, rash, golf ball size knot,  limited mobility and MD looked at it 2 weeks later gave motrin and return to MD  in 1 month  ultrasound to rule out blood clot, and then 1 month and 2 weeks back to MD for antibiotics and treated for infection.   6/22/2021 MD treating with antibiotics  swelling improved, mobility better.
Mom noticed left thigh was swollen, warm at site of immunization during his nap this afternoon 6/29/10; acting fine otherwise - walking well. No fever. Normal appetite. No acting fussy. Assessment: bacterial vaccination reaction; left ant thigh. Plan: cold compress, TYLENOL prn. Return to office if decrease in use left leg; development of fever and irritability.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of the several reports received from the same source. Additional information has been requested.
chills; a 102°F fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (a 102°F fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Fibromyalgia and Cholesterol blood excessive.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (a 102°F fever) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, CHILLS (chills), PYREXIA (a 102°F fever) and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 f 102 F.     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.   concomitant medications included medicines for high blood pressure, fibromyalgia, cholesterol.
The pt was vaccinated on 7/25/00 and on 8/8/00 was seen in a clinic with pruritis, erythematous at the injection site. Was warm to the touch with swelling 30x55 mm. No rash. Pt reports that she developed a mild outbreak of chicken pox on both arms and legs. The vesicles completely dried by 8/13/00.
This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 21-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M007279 with an expiration date in 09-FEB-2018), for prophylaxis that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572.
19SEp95 devel flu like sxs, myalgia & rash on torso only & rash resolved p/24hrs; unsure if had temp; 20SEP95 devel wrist swelling which progressed to all joints swelling w/edema in both knees by 22SEP95; c/o arthralgia;wrist swelling gone
Couldn't swallow; Throat was dry; no Saliva in mouth / mouth dry; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry). At the time of the report, DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Migraine severe after 2nd dose; Sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer, Concussion (history of previous concussion age 16 MVA behind right eye (rolled and hit tree),), Vertigo, Headache, ADHD (ADHD/ADD (briefly took medication as adult).), Motor vehicle accident (MVA age 27 sideswiped. Also had 4 other MVA's. All of which felt better within a fewdays) and Hysterectomy (Hysterectomy at the age of 30, due to ovarian cancer) on 14-Mar-2008. Concurrent medical conditions included Migraine (Behind right eye  (average about 1-2 per month)) since 1987, Irritable bladder (Ibs hypothyroidism) since 01-Nov-2000, Hypothyroidism (Ibs hypothyroidism) since 01-Nov-2000, Allergy to nuts (Tree nuts), Drug allergy (Morphine), Claustrophobia and Cystitis interstitial (IC). Concomitant products included URIBEL for Cystitis interstitial, LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (CLIMARA [ESTRADIOL]) and SUMATRIPTAN for an unknown indication.   On 16-Apr-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021 at 2:00 AM, the patient experienced MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting). At the time of the report, MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No treatment information was provided.   This case was linked to MOD-2021-083105 (Patient Link).
Information has been received from a physician concerning a 76 year old female with cholesterol high, gastrooeseophageal reflux disease, degenerative joint disease, neuropathy peripheral and drug hypersensitivity and a history of coronary stent placement who on 16-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LANOXIN, PLAVIX, aspirin, PREVACID, NIASPAN, COZAAR, folic acid, OXYCONTIN, LASIX, spironolactone, VICODIN, PAXIL, ZOCOR, amitriptyline hydrochloride, SENOKOT-S TABLETS, METAMUCIL and calcium (unspecified).  In October 2007, the patient experienced red spot on forehead and tenderness on the head.  The tenderness on the head is mainly the area surrounding the forehead.  The patient was sent to urgent care and received unspecified antibiotics.  The patient called on 05-Nov-2007 to report the red spot near the left eye.  The medical assistant could not determine if the red spot is a rash.  The patient's red spot on forehead and eye, and tenderness on the head persisted.  Unspecified medical attention was sought on 02-Nov-2007.  No product quality complaint.  Additional information has been requested. This is infollow-up to report (s) previously submitted on 12/21/2007. Follow-up information received from the healthcare professional indicating that the patient has an allergy to "TOPROL". The  patient received the vaccination subscutaneous in the left arm. On 11-OCT-2007, the patient experienced inflammation of the forehead. Patient went urgently to care facility and was given "cephalexin" 500 mg. The patient later experienced another area of inflammation. Both have resolved. No further information is expected.
Felt like a combination of flu and cold and other.  Meaning, no fever or chills, but very very lethargic.  Overall unwell feeling.  Claminess.  The way that I felt for 3 weeks after was unlike anything I've felt before with the combination of symptoms.  Started feeling pretty normal after about 3.5 weeks.
Diagnosis - atrial fibrillation Treatment - asprin Symptoms - 8/15/2021 9:30 p.m. shortness of breath, heart palpitations.  aFib seized 8/16/2021 at 6:30 a.m.
Felt a couple or few drops running down arm/entire dose wasn't administered; A spontaneous report was received from a consumer, unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) which resulted in few drops running down arm and entire dose wasn't administered to patient.  The patient's medical history was not provided. No concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient felt a couple or few drops running down bared arm and entire dose wasn't administered. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "few drops running down arm and entire dose wasn't administered to patient" was considered as resolved on 16 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection which resulted in few drops running down arm and entire dose wasn't administered to patient. There were no reported adverse events after the vaccine was administered in this case of incorrect dose administered and exposure via skin contact.
By morning following vaccine (each time) had fever, cough, body aches, last 1-2 wks
Redness, itching, swelling and hard lump that radiates heat at the injection site that began one week after the first dose of the vaccine.
Fever, chills, muscle ache, headache, tiredness, lasted approximately 14 hours. Very sore at injection site, lasted 2 days. This was the 2nd shot of the shingrex series. Same symptoms were evidenced after the 1st shot, also.
I95.9 HYPOTENSION 10/17/2022 HTN (HYPERTENSION) J96.00 ACUTE RESPIRATORY FAILURE 10/21/2022 HTN (HYPERTENSION) I95.9 HYPOTENSION 10/17/2022 HYPOTENSION J96.00 ACUTE RESPIRATORY FAILURE 10/21/2022 HYPOTENSION
Fever, chills, nausea, headache, body aches. Not abating six days after vaccination.
SARS coronavirus 2 RNA:PrThr:Pt:Respiratory:Ord:Probe.amp.tar performed on 7/20/21 at 09:45. Test came back positive. Case investigation interview with patient has not been performed as of the time of note.
Patient has a red circle around the area of injection on her left arm (from the Boostrix).  She said it itches.
hives; rash; swollen eyes; redness; Inflammation; This is a spontaneous report from a Pfizer sponsored program support received from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  In Mar2021, a week later, the patient experienced hives, rash, swollen eyes, redness and inflammation. The outcome was not recovered for redness and inflammation and unknown for rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; no further information is expected
Error by vaccine administration nurse, 0.2 mL given by nurse on 3/2/21 at Clinic. Client was called at 6:20 pm  on 3/2/21 and did not answer. Voicemail explaining situation with call back number was left.
8-29-08 1530 TELEPHONE CALL FROM GRANDMOTHER OF INFANT REPORTING INFANT HAD DEVELOPED A RASH THAT NIGHT AFTER RECEIVING BABY SHOTS ON 8/29/08. ADVISED GRANDMOTHER TO TAKE INFANT TO ER SINCE INFANT DID NOT HAVE AN ASSSIGNED PROVIDER YET. THE RASH WAS ON INFANTS FACE,CHEST,BACK,AND GENITALIA BUT NOT ON ARMS OR LEGS. NO FEVER OR OTHER SYMPTOMS. Infant seen after 08-29-08 and the Dr said lets just wait and see if the rash goes away. spoke with grandmother on 9-2-08 and she reports the rash ahd gone away and no other symptoms.
PT STATES SORENESS IN ARM THAT RECEIVED PNUEMOVAX.  MENTAL DISORIENTATION FOR 2 DAYS, VERTIGO, HEADACHE, GENERAL MALAISE, UNABLE TO DRIVE VEHICLE.
Entire Upper arm is red, swollen and firm around injection site and has been for 3 days
Shortly after the patient was administered a first dose of Covid-19 vaccine at around 3:05 pm on 1/07/21, the patient experienced troubled breathing, chest tightness and wheezing for several minutes.  The patient described her condition as, "my throat feels like it is closing up."  An epipen was given at 3:12 pm and the patient reported improvements at 3:16 pm (four minutes after the epipen was given).  Emergency services was called and reported to the scene at 3:12 pm where they noted the patients improved condition, after the epipen was administered.
Hoarseness throat swelling, itching. VS at 1153: BP 174/115, HR 83, O2Sat 100.   VS at 1159 BP 149/107, HR 90, O2 Sat 100% Pt was awake alert and oriented x4, heart + lungs clear to auscultation, no stridor, no hives, no tongue/lip/face/oropharyngeal swelling, cap refill < 2 seconds Received 25 mg IM Benadryl with resolution of symptoms, just some mild residual itchiness. EMS/ED advised, Pt declined and was advised to seek emergent medical evaluation if symptoms worsen or return. Pt was advised not to drive herself
Itching, Worst the 1st wk, Taporing off to the end of 3 wks /p shot. Itching in area of shot, upper rt arm.
Infant developed inconsolable crying and fussiness for several hours after receiving shots. Continued for 3 days
shingles from the shingles shot/ Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Until the date of reporting the patient thought that the patient was the only one to get shingles from the shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The healthcare professional reported that a few hours after receiving the SHINGRIX, the patient experienced excruciating pain at the injection site which radiated down to her arm. The patient's daughter had given her ibuprofen 800 mg every 8 hours for 2 doses. In the morning after receiving treatment, the patient was feeling better but had some pain, at the time of reporting.
An expired dose was given with no reported adverse event; Initial information received on 13-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non health care professional via Global Media Information (Under reference 00727701).  This case involves a patient (unknown age and gender) who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 10-Aug-2021, the patient received a dose of suspect ACT-HIB (lot number: not reported and expiration date: 25-Jul-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "We would like to know if there is a significant degradation in potency for the vaccine if it was roughly 2 weeks past its expiration date. Please advise".  At time of reporting, the outcome was unknown for the reported 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 the 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 on the batch number for this case.
Soreness at injection site (level 2 on scale 1-10); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Oct2021 09:30 (Lot number: FF2593) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Nephrotic syndrome" (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS taken for nephrotic syndrome, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (DOSE:1, prev dose lot number=FH8020, prev dose administrator route=Intra muscular,, prev dose dose number=1,, prev dose vaccine location=Left, arm}], administration time=03:15 PM), administration date: 09Oct2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021 20:00, outcome "not recovered", described as "Soreness at injection site (level 2 on scale 1-10)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient did not have any known allergies. The patient did not have any family medical history relevant to adverse event.  No follow-up attempts are possible. No further information is expected.
ran a fever PM of 21SEP92 of 105.6 & was delirious; mom gave tepid bath & APAP;
swelling in hands and ankles.  tingling in hands arms feet. swelling on and off