chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Became very ill; Nausea; Running a fever; Pain in my joints/ pain in my elbow; Pain in my underarm; Lymph nodes are the size of a golf ball; Extreme swelling in my left arm; Huge big ball of skin coming out; extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided.  Concomitant products included GABAPENTIN for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MALAISE (Became very ill), NAUSEA (Nausea) and PYREXIA (Running a fever). In August 2021, the patient experienced PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball). At the time of the report, MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), NAUSEA (Nausea), PYREXIA (Running a fever), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
fatigue; dizziness; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 67 years) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After the first dose of the vaccine, 3 days after experienced fatigue and dizziness. She was on the sofa all day. The dizziness and fatigue lasted on and off for 2 days but not the same degree. It was also reported that the patient received the 2nd dose of the Pfizer vaccine on 12Feb2021 (lot: EL9267). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
PATIENT RECEIVED MODERNA VACCINE 12/31/20. PATIENT NOTIFIED PHARMACY 1/8/21 OF RASH ON ARM THAT OCCURRED HOURS AFTER VACCINATION. SHE STATED THE RASH WAS NOT SORE BUT ITCHY AND WARM TO TOUCH. SHE THOUGHT THE RASH WAS IMPROVING BUT INSTEAD THE VACCINE SITE TURNED DARK IN COLOR AND THE MUSCLE WAS FIRM. THE RASH DID NOT SPREAD FROM THE INJECTION SITE. PATIENT WAS CONCERNED SINCE LITTLE INFORMATION IS AVAILABLE FOR MODERNA. THE PATIENT WAS ADVISED TO SEEK MEDICAL ASSISTANCE IF NEEDED. FOLLOWED UP WITH THE PATIENT 1/11/21. THE PATIENT SAID THE RASH STARTED TO IMPROVE 1/10/21. THE RASH WAS NO LONGER ITCHY, DARKNESS WAS FADING, AND THE MUSCLE WAS LESS FIRM. PLAN TO FOLLOW UP WITH PATIENT AGAIN LATER THIS WEEK.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media  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 provided as follows The case was reported for the reporter's father. The age at vaccination was not reported. the patient received Shingles vaccine in his 70s. The patient never had the shingles until he received Shingles vaccine. Afte receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
I had a lot of pain in arm from first dose, but nothing else. With this dose I have had a bad migrane since last night, lasting all day today and came down with a fever around 2 pm today which started mild but got up to 102.5  I"m taking Tylenol which helps   I also have all over aches and am a little nauseous.  None of this happened with first dose. Under an abunence of caution I am quaranteening myself from my family, just in case it is covid related
This spontaneous report was received from a Healthcare Student refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 21-AUG-2014 the patient was vaccinated with PNEUMOVAX23 lot# J0006242, intramuscular (dose strength not reported). No concomitant medication was J006242; expiration: 03-AUG-2014, patient received an expired dose of PNEUMOVAX23 (lot# J006242; expiration: 03-AUG-2014). No known adverse effects were reported. The outcome of received expired dose of PNEUMOVAX23 was unknown. No PQC was involved. Additional information has been requested.
Per MD Note: "Acute throat and upper chest pain this AM. At approximatley 0300, he woke up with severe 10/10 chest pain. The pain is sharp and he points to the midline between his collarbones. He went to an ED and received a GI cocktail and famotidine, which did not provide much benefit. He had an elevated troponin to 2.13, EKG without evidence of pericarditis. He was given 0.5 mg Ativan and 15 mg IV Toradol. Workup notable for CXR (wnl), EKG (wnl), CRP (2.2), ESR (29), proBNP (62 wnl). Lipase (wnl), Lithium 0.8 (0.6-1.2 mmol/L). CMP 142/3.9/106/27. BUN 12, Cr 0.75. Dexi 120. Upon arrival to our ED, he reports 1/10 chest pain. He denies any SOB, difficulty breathing, palpations, abdominal pain, nausea, vomiting, or diarrhea.    He received his second Pfizer COVID-19 vaccination on 7/19 and has had low grade fever (Tmax 100.5F), myalgias, tiredness, and headache since then. He reports that his chest feels slightly tight, but denies any SOB. Assessment: Patient is a 15 y.o. male presenting with acute onset of chest pain and elevated troponin. Workup has been extensive and including BNP, repeat troponin, EKG, CXR, and echocardiogram. He does not show evidence of severe myocarditis or pericarditis. Assessment by cardiology suggested that mild myocarditdis in the setting of recent COVID-19 vaccination and acute heart strain/troponin leak in the setting of acute pain"
Pt became lightheaded, pale, passed out for approx. 45 seconds. BP 108/67. Pulse 56
Rash on back similar to shingles but across back, both sides. Appears to follow nerve paths.
It was reported that a female pt received Fluzone SV 98-99 USP vaccine on 10/28/1998. Reportedly sometime after the vaccination the pt experienced swollen sore arm and itching.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; METFORMIN; TRAZODONE. Past drug history included: Metronidazole, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Clinical course: Symptoms were resolving and COVID antigen test was negative on Day 9. Then COVID symptoms returned on Day 10 and COVID antigen test was positive. Resting and symptomatic on day 14 still with positive antigen test and COVID symptoms. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 13Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swollen tongue; sleepiness; swollen tongue, with raised white puffy lines; had Fluzone Quad vaccination in 2009 and had a reaction and had the moderna COVID and had a reaction as well; rash; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Global Media Information (under the reference 00787220).  This case involves a 57 years old female patient who experienced swollen tongue, sleepiness (somnolence), swollen tongue, with raised white puffy lines (tongue discolouration), had fluzone quad vaccination in 2009 and had a reaction and had the moderna covid and had a reaction as well (vaccination complication) and rash after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LEVOTHYROXINE SODIUM (SYNTHROID).  In 2009, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, lot U3261AA and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious swollen tongue, sleepiness (somnolence), swollen tongue, with raised white puffy lines (tongue discolouration), had fluzone quad vaccination in 2009 and had a reaction and had the moderna covid and had a reaction as well (vaccination complication) and rash (unknown latency) following the administration of vaccines  No laboratory data reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At time of reporting, the outcome was Unknown for the reported events.
Symptoms 01/08/2021   fever, body aches, headache and sore throat unresolved 02/15/2021    Onset of arm heaviness (trouble doing hair, lifting arms etc.), c/o feeling leg heaviness (having to lift legs while climbing 1 flight of stairs), felt "like my legs weren't working, something is wrong" 03/30/2021   progressive worsening of weakness to upper and lower extremities with ataxia (need to kick legs forward to walk), inability to take a deep breath, ineffective coughing 03/31/2021     Development of slowed swallowing (while swallowing yogurt and fruit it would take 5-6 attempts at swallowing); off work 08/14/2021    Joint pain started  08/23/2021    symptoms of weakness return and "brain not working right" Fog, wo
I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642426 same vaccine/reporter/AE, different patient
On the 8th of this month,  I began to experience sinus/ allergy like symptoms. My husband had tested positive with the same symptoms the day before. I tested on Friday with positive results.  It was a rapid test.
56 year old man presented with dysesthesias in his distal legs and hands, and then shortly after developed weakness in his feet, legs, hands and difficulty walking. He had his second Moderna Covid-19 vaccination on 9/10/21 with these symptoms developing an estimated 5 days later. His physical exam is remarkable for intact cranial nerves, strength is 4/5 (reduced) in both legs and most severe with ankle flexion/extension. Intrinsic hand muscle strength 4/5.  Sensation intact to light touch and pin prick. Reflexes were diffusely absent. Lungs clear, heart regular without murmur, abdomen non-tender with intact bowel sounds. No rash.   He was diagnosed with Guillain-Barre syndrome and treated with IVIG 400mg/kg for 5 days. He is currently on day 3 of treatment (9/24/21). Clinically he has remained stable since receiving IVIG. He did not have an EMG/nerve conduction study.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Delivery (Patient received fertility treatments with first child; Pregnancy outcome: Live, full-term birth) on 11-Feb-2020. Concurrent medical conditions included Food allergy (Allergic to Butternut squash). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 03-Mar-2021 to an unknown date for Pregnancy.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 25-Oct-2021. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pregnancy test: positive Positive. On 15-Mar-2021, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
Report received from a microbiologist on 08-OCT-2010. (Via distributor Merck case# 1010USA01081). A female patient (DOB: unknown) received AFLURIA (batch unknown) on 06-OCT-2010 for a flu-shot. The patient's medical history and concomitant medications were unknown. On the 07-OCT-2010, 24 hours after receiving the suspect drug, the patient experienced numbness on the left-side of her face. The microbiologist said the patient was given prednisone and a Lyme disease titer-test was performed on the patient. The patient did not seek medical attention. The adverse event did not improve and the patient had not recovered on reporting. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up information received on 22-NOV-2010. Original report was from a pharmacist (medically confirmed).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 152, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter stated that her doctor had heard of a lots of patients who experienced a sore arm after vaccination with SHINGRIX. The reporter did not have any additional details regarding this event. This case was linked with case US2018179125, reported by the same reporter.
25 hours post vaccination, entire upper arm got swollen, red, tender and hot to touch.  Rx - benadryl, not taken because pt is nursing.
Headache Hot and cold, with temp of 100 degrees Severe joint paint Could not sleep
No additional AE details; Inbound call from HCP reporting that a PROQUAD was administered after a supported temp excursion.; This spontaneous report has been received from a physician, concerning to a 15-months-old patient of unknow gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided.  On 30-SEP-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number W019624 that was verified to be valid with an expiration date reported and established as 19-DEC-2023) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion of 15.1 degrees Fahrenheit (F) during a time frame of 3 hours and 49 minutes with 0 seconds. There was not a previously temperature excursion reported; and it was mentioned that varicella (oka-merck) virus vaccine live (PROQUAD) was administered after a supported temperature excursion.  There was no additional adverse event (AE) reported (no adverse event).
Headache, Fever, CHILLS,JOINT PAIN, BODY ACHES, FATIGUE, NAUSEA Narrative:
Itching to the point that she would scratch and draw blood and would not sleep. Horrible rashes and hives. Eczema so bad that it looked like chicken pox at one point. Severe food allergies, histamine intolerance and SIBO/gut dysbiosis so bad that she can currently eat 5 foods safely at 20 months old. Failure to thrive... she didn't gain any weight for 6 months.
RespDepression, NauseaVomiting, Malaise and weakness also reported. Narrative:
Fever over 102. Chills. Headache. Extreme body aches. Nausea. Swollen, itchy arm at injection site.
SWEATS; COVID SYMPTOMS; ABSOLUTELY WRECKED; MENTAL FOGGINESS; UNABLE TO RESUME NORMAL PHYSICAL ACTIVITY; BARELY ABLE TO STAY AWAKE/GROGGINESS; COULD NOT WORK; COULD NOT DRIVE; FATIGUE/EXHAUSTED/TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On OCT-2021, the patient experienced mental fogginess. On OCT-2021, the patient experienced unable to resume normal physical activity. On OCT-2021, the patient experienced barely able to stay awake/grogginess. On OCT-2021, the patient experienced could not work. On OCT-2021, the patient experienced could not drive. On OCT-2021, the patient experienced fatigue/exhausted/tiredness. On OCT-2021, the patient experienced no energy. On 06-OCT-2021, the patient experienced absolutely wrecked. On 07-OCT-2021, the patient experienced covid symptoms. On 07-OCT-2021, the patient experienced sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweats, had not recovered from covid symptoms, mental fogginess, fatigue/exhausted/tiredness, unable to resume normal physical activity, no energy, barely able to stay awake/grogginess, could not work, and could not drive, and the outcome of absolutely wrecked was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
FELT SICK ON JUNE 25TH AND REPORTED TO EMERGENCY ROOM. ADMITTED FOR BLOOD CLOT IN LUNG
12-14-09 Patient states in evening of day of her vaccine she started having vomiting and diarrhea. 12-15-09 thru 12-17-09 Felt lightheaded and dizzy, c/o intermittent headache. When patient came into employee health 12-17-09, stated vomiting and diarrhea ceased evening of 12-14-09, felt lightheaded, B/P 130/70. 12-18-09 Only symptom intermittent headache.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 15-SEP-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: