chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Disseminated BCG; Information has been received from the authors of a literature, titled as stated below, referring to a 7-month-old infant with with inborn errors of immunity (IEI), homozygous IKBKB gene mutation. Concomitant medication was not reported.  On an unknown date shortly after birth, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) indication was not reported, however it was defaulted to Tuberculosis bladder.  By 18 days of life, he had suffered from a persistent cough and recurrent rhinovirus infection prompting hospitalization. At 3 months of age, he underwent bronchoscopy for persistent pneumonia, at which time BAL fluid cultures were positive for Streptococcus pneumoniae, Klebsiella oxytoca and Stenotrophomonas maltophila, requiring intravenous antibiotic treatment. He later developed necrotizing pneumonia with Burkholderia cepacia complex and S.maltophila raising concern for an underlying IEI. His initial chest radiograph revealed a left lower lobe con solidation with pleural effusion. His chest computed tomography was significant for a left lower lung consolidation and two nodules in the right upper lung. When this imaging finding was compared to a computed tomography of the chest obtained 2 months prior, the consolidation was noted to be markedly decreased in size. On hospital day 29, a bronchoscopy was performed and BAL fluid specimens were obtained. At 8 months of age (5 weeks into his hospitalization), the boy's mother reported that new, painless skin nodules had developed over the prior month. On examination, the infant had new hyperpigmented nontender skin nodules over his left deltoid, his left posterior shoulder, and his right posterior thigh. The lesions were concerning for disseminated fungal or mycobacterial infection. A Karius plasma mNGS test was sent and positive in 72 hours for MTB complex (369 molecules per milliliter, ref less than 10). This prompted treatment and work-up for disseminated mycobacterial infection. A tissue biopsy was obtained of his right posterior thigh lesion. Histopathologic examination of his skin biopsy revealed granulomatous inflammation. The biopsy was acid-fast bacilli (AFB) smear and culture positive. Gastric and blood cultures were positive for MTB complex 34 weeks after collection, later identified as M bovis-BCG. MTB complex PCR from the skin lesion was positive, but MTB complex PCR testing from blood, gastric aspirates and CSF was negative. The infant was treated with antimycobacterial therapy for a total of 14 months following engraftment. He was doing well clinically and continues to follow-up with the bone marrow transplant team for post-transplant care.  The reporter considered the event to related to the bcg live (manufacturer unknown).  Upon internal review, the event Disseminated BCG was considered to be medically significant.    A copy of the published article is attached as further documentation of the patient's experience.
States that evening extreme soreness in arm that ice, Tylenol, ibuprofen and prescription stronger medication did not ease pain. Almost unable to move Tuesday, feels like it is in the bone/tissue.  Urged to call PCP as soon as possible.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced 9 X 9 centimeter swelling at the injection site.  At 3 years of age, the patient received the first dose on 06-May-2010. The patient experienced 9 X 9 centimeter swelling at the injection site on 07-May-2010.  The outcome is unknown.  No additional information was available at the time of this report.
This spontaneous report was received from a medical assistant of unknown age regarding herself (female). The concurrent condition, medical history and concomitant medication was not reported. On 15-JUL-2009, the patient was vaccinated with the first dose of hepatitis b virus vaccine (manufacturer GlaxoSmithKline). On 25-AUG-2009, the patient received the second dose of RECOMBIVAX HB 5/0.5 microgram/ml (route and lot details unavailable). The patient reported that she would like to receive a third dose of RECOMBIVAX HB now. No adverse symptoms were reported. Additional information has been requested.
Pt received immunizations (FLUMIST, HepA/B, Meningococcal, MMR, and Pneumococcal) on 7/1/09. He denied any local reaction. The pt was seen in medical on 8July09--the pt had fallen while running and injured his right knee. In reflection the pt remembered a feeling of weakness in both of his thighs. He was treated with naproxen and states that he felt ok on the 9th of July. The pt reported to medical on 20July09 with complaints of fever, sore throat, headache, cough and chest congestion for approximately 10 days. The pt remembers that several members of his platoon were sick with the same symptoms. The pt also complained of sharp, shooting pain in both of his legs and weakness in both of his arms. He denied having bowel or bladder incontinence at any time. The pt states that he experienced about 4 falls prior to this medical appt (he had intermittent numbness/weakness in his legs which seemed better after a night's sleep). The pt was released but he returned at 1030 stating that his legs were numb, his legs were weal (R>L). The pt was taken to a civilian ER. He had a CT scan of his head and spine (see below). The pt was discharged to full duty. On 21 July 09 the pt had difficulty walking--he fell and he required assistance to ambulate, he could not hold up his head--he felt a constant, throbbing, pressure in his neck and back, and he was having difficulty swallowing. The pt was seen by a civilian neurologist who performed an NCS (see results below). The pt was admitted to hospital with GBS. At his worst he needed assistance with getting out of bed, standing transferring; he had difficulty chewing and swallowing; and difficulty lifting his arms to feed himself. The pt received a 3 day course of IV IG .8mg/kg with improvement in his symptoms. After 4 days he was transferred to acute rehab. Prior to discharge the pt was able to swallow, he was able to walk short distances with support, his arms were weak. As of 8/27/09 the pt had no issues with swallowing or chewing. His fatigue was 60% better. He was able to feed himself and had adequate arm strength and movement to performs ADLs. He was unable to perform any pushups (prior 44), no pull ups (prior 4-5), no sit-ups (prior 88). Previously he could curl 25-30lbs and now he can curl 9 lbs for 10 reps. He fatigued within 2-3 minutes of performing on the arm bike. He was able to ambulate short distances without assistance otherwise he used a cane; he could walk on the treadmill for about 1/2 mile before he fatigued. According to the pt he had made no progress in the last 7-10 days. He is currently a pt on the "light care" unit at the hospital. 11/20/2009 ED and MR for 7/21-7/24/2009.Dx GBS  Patient with c/o's progressive extremity weakness and dysphagia. Neuro exam noted hyporeflexia. Tx: IVIG, LP,  evaluated for PT, OT and ST , dc'd to inpatient rehab for continuing care 12/10/09 Medical records received for DOS 07/24/09- 07/31/09 (Rehab Inpatient Unit) and  07/20/09-9/09/09 (PCP records) Following discharge on 07/31/09, Pt. reports fatigue improving; Physical therapy reports increased muscle strength and improved balance.
A sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Yearly IM Flu vaccine Fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. In October 2021, the patient experienced VACCINATION SITE PAIN (A sore left arm). At the time of the report, VACCINATION SITE PAIN (A sore left arm) had resolved.   Concomitant medications included High Blood Pressure Medication (unknown brand). No treatment medications were reported. patient experienced a similar event in the past   This case was linked to MOD-2022-547040, MOD-2022-547043, MOD-2022-547048, MOD-2022-547048 (Patient Link).
EXTREME weakness.  Completely collapsed getting out of bed.  Mother called 911, and he was transported to hospital emergency room.  EXTREME mental confusion and after being discharged from hospital colapsed again,  Had two people get him to bed, and them he slept without moving an inch from about 6AM until 11PM without going to bathroom, eating, or even rolling over.  When he woke up, he yelled out to us in another room.  He told us he was hungry.  We took him food, but he was too weak to even hold the spoon or hold up his head.  We had to hold up his head and spoon feed him.  He went back to sleep, and he slept for almost 24 hours more.
Ten days after vaccine had severe abdominal cramps, diarrhea, rectal bleeding and vomiting for about 4 hours.
Information has been received from a physician's assistant concerning a 20 year old female with syncope episodes in the past after receiving other vaccines who on 13-FEB-2008 was vaccinated with a first dose of GARDASIL IM. On 13-FEB-2008 the patient fainted. The representative reported that the "patient had not eaten breakfast before being vaccinated". On 13-FEB-2008, the patient "was fine before leaving the office." No further information was provided. Additional information has been requested.
the patient was not of age to receive the vaccine, the patient was 4 and needed to be age 5 for the vaccine (received an unauthorized vaccine)
Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old female patient who experienced area was swollen and puffy and area or redness at the injection site- involved 4.5 to 5 inches. At 3 years of age, the patient received the first dose in 2010. The patient's concurrent illness includes therapy regimen changed (patient received 4 doses of PREVNAR 7 vaccine in the past). Healthy child. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced area was swollen and puffy at the injection site-involved 4.5 to 55 inches and area of redness at the injection site on an unknown date in 2010. Unknown immunizations had been administered to the child at the same time (vaccines and administrations sites were not reported). The physician had the child come in to the office daily and ice was applied to the site. The redness and swelling resolved on an unknown date in 2010. No additional information was available at the time of this report. Follow-up (17Nov2010): This is a follow-up report from a contactable health care professional. Vaccination Lot #: E47475. The vital statistics at time of adverse event included a weight of 33 lbs and a height of 3ft 3/4 inches. The health care professional administered the vaccine to the patient. The vaccine was not altered in any way to accommodate administration. The medicine was stored as per manufacturer's instructions. Developmental milestones including language/speech, emotional/social, fine/gross motor skills, and cognitive thinking were all with normal range. The child has not failed to meet any developmental milestones since receiving the vaccine. The child's physical growth has been normal. The outcome of the event is recovered.
pt recvd vax; devel hives, cough, chest tightness, throat closing feeling 45 mins p/ shot; lasted 2 hrs w/ dph;
Diagnosed with COVID arm by my doctor?s office. Red, itchy rash surrounding the injection site on my left arm, and is about 3 inches long and 3.5 inches wide. The rash does not have any bumps I can see, but is itchy, red, and warmer to the touch than the rest of my arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Negative, notes: for Covid on last day of treatment, but rebounded; Positive, notes: 4 days later with infectious symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild headache, lasted only 2 hours.  Injected arm was sore starting 3 hours after injection until the next day at 5pm.  (pain comparison, felt bruised)
MEDI-0003483 is a non serious spontaneous case from a consumer in USA involving flu like symptoms. The reporter causality is not provided to FluMist. A 40 year old male received FluMist on Oct 27 2004 at 1:48 pm. 3-4 days after receiving the vaccine, patient experienced nasal congestion. On the 6th day, the patient felt worse with more flu like symptoms and felt that he developed full blown influenza, He complained of chest congestion, cough, muscle aches, fever and nausea. The patient called his doctor to inform him of his symptoms. He was advised to stay home and rest. His doctor reported the symptoms he developed to the Center for Disease (CDC). After a month, the patient fully recovered. He was then seen at his doctors office where a nasal swab was taken but he did not know what the result was. Per nurse at doctors office, there was no record on patients chart that a nasal swab was done at their office. The reporter felt the events are possibly related to FluMist, although he stated that he was also doing some paint jobs a few days after he received FluMist. The patient fully recovered. Additional information incorporated in narrative. AE onset date.
4 hrs after shot I started to feel nauseous and lightheaded. By 6:30pm I had also had abdominal cramping, headache, vertigo, fatigue, a mild fever and joint pain in addition to the nausea. These symptoms worsened over the course of the night until the fever broke around 2:30am. The highest I remember the fever getting was 101.3 degrees, taken with both a forehead and ear scan thermometer. This morning I have abdominal soreness and fatigue but no other symptoms.
Pain in back, left arm, 8/10 pain, 10 being worst.  Nausea, Dizziness, Fast heartbeat.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-JUN-2017, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-OCT-2007, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
tiredness; sore arm when she touched the injection site; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site). At the time of the report, FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Started Guanfacine 1 mg twice daily and Prozac 10 mg every other day on Monday, April 11, 2022. Saturday April 16, 2022 began having dull ache in back and left arm, discontinued Guanfacine. Thursday, April 21, 2022, collapsed and was unable to be resusitated. Pronounced dead.
Information has been received from a published literature article. Over 16,000 patients were listed for liver transplantation (LT). The medical evaluation prior to listing for LT was rigorous and included screening for potentially preventable infections like viral hepatitis and Pneumococcus. Super-infection of hepatitis A (HAV) or hepatitis B virus (HBV) in patients with cirrhosis can lead to decompensated liver failure and increased mortality. A study of LT candidates showed that almost three quarters met criteria for needing HBV vaccination, but screening and vaccination rates were unknown. This study aims to determine the frequency of HAV, HBV and pneumococcal screening and vaccination at a high volume LT center. There were 297 patients on the LT list in July 2014. The cohort was 63% male with median age 60 years and 49% having hepatitis C cirrhosis. The median listed MELD (Model For End-Stage Liver Disease) was 17 and 39% had hepatocellular carcinoma. Overall, there was nearly universal HAV and HBV serologic testing (97% and 98%, respectively). Hepatitis B surface antibody (HBsAb) was positive in 36% and 127 (43%) had either positive hepatitis B surface antigen (HBsAg) or isolated core antibody. There were 123 HBsAb negative candidates without chronic HBV qualifying them for HBV vaccination. Only 23/123 (19%), candidates received HBV vaccination. Of 14 patients with repeat post-vaccination HBV serologies, 9 (64%) achieved seroconversion. Pneumococcal vaccine was more frequent with 63/297 (21%) having a documented vaccination. There was no association between age, gender, listed MELD, and etiology of liver disease on the likelihood of receiving any vaccine. This is one of 2 reports received from the same literature (other case # 1505USA015709). Additional information has been requested.
Petechiae on upper arms, chest; Mottling of thighs and legs; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 03Apr2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issues, insulin resistance, PCOS and iron deficiency anemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and inositol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. On 03Apr2021 at 22:00, the patient experienced petechiae on upper arms, chest; mottling of thighs and legs which cleared up after 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events petechiae on upper arms, chest; mottling of thighs and legs was recovered on 05Apr2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 24Apr2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Swollen left eye lid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 10:45 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: FLONASE. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 02Sep2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 23Sep2021 11:15, outcome "recovered" (Sep2021), described as "Swollen left eye lid". Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information: Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19. Patient received other medications in two weeks was Flonase. No known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer service representative from a company called physician sales and service reports that a physicians office reported to him that a patient experienced an adverse reaction to the PNEUMOVAX 23 (lot # 665924/0930Z). Adverse experienced unspecified. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was not reported. This is an amended report, the fields of "vaccinated at" and "vaccine purchased with" have been entered as unknown. Additional information has been requested.
Beginning at 8:00 pm on 2/2/21 I had severely sore arm, chills, severe body aches, and fever until 8:00 am 2/4/21. Starting at 6:00am 2/3/21 I also had nausea and abdominal pain until 8:00am 2/4/21. Headache began 8:00 pm 2/2/21 and continues as of 11:15pm 2/4/21.
Information has been received from a health profession concerning a 13 year old female with no pertinent medical history reported who on 17-FEB-2010 was vaccinated intramuscularly into the left deltoid with second dose of GARDASIL (lot number 663454/0672Y). On 18-FEB-2010, the patient experienced swollen itchy eyes. The patient recovered from swollen itchy eyes on 19-FEB-2010. The patient did not seek medical attention. Additional information is not expected.