chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2021, the patient received Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient was vaccinated with Shingrix and experienced  body aches.  The patient wanted to know how long do the last?
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.18.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35 total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 08 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Chills; Aches; Nausea; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included psoriasis.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norethisterone (VYFEMLA); for an unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient previously took tramadol and codeine and experienced drug allergy on an unknown date. On 15Apr2021 at 08:00, the patient experienced chills, aches, nausea and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. 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 events chills, aches, nausea and swollen lymph nodes were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt. developed severe pain and decreased range of motion of left arm after Tetanus-diphtheria injection.  She is taking nonsteroidal anti-inflammatory medication and undergoing physical therapy.
PATIENT ADMITTED TO HOSPITAL 9/30/21 WITH PROGRESSIVE SOB, COUGH, POOR APPETITE, BODY ACHES, LOSS OF TASTE. DIAGNOSED WITH CVODI19 DURING ADMISSION. ISSUES WITH MAINTIANING BP AND OXYGENATION DURING HOSPITALIZATION. CODE BLUE CALLED 10/10/2021, ACLS INITITATED, NO ROSC AFTER 18 MINUTES, FAMILY ASKED TO STOP RESUSCITATION EFFORTS. DIED 10/10/2021 AT HOSPITAL.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with RECOMBIVAX HB (dose of 0.5 ml once, intramuscular) (lot and expiration date not reported) that were stored at 11C for an unspecified time period. No concomitant medications were reported. No adverse effects reported. The reporter stated refrigerator consistently was reading in range between 36 and 46F (2 to 8C) for month of March 2014. Additional information has been requested.
Pre dialysis on 10/30/09 complained of achiness (generalized), feeling cold, difficulty breathing. Lungs were clear (oxygen administered w/ ease of breathing), BP 129/41, HR 81 - regular temp 98.38. TYLENOL given for pain #7/10 on pain scale. Patient 3.4 kg > EDW. Edema +2 pitting in right leg. Reported patient condition to Nephrologist. Hemodialysis treatment initiated and completed without complication. Patient refused to be evaluated at ER and discharged home in stable condition.   11/13/09 Medical records received. Dialysis records for DOS 10/28-10/30. C/o fainting x3 at home. Can't stay awake. Vaccine given same day (10/28).  Admits he had called 911 x2 looking for help that day. Seen 2 days later and c/o coldness, hurting all over. Can't breath. Kept asking for help. Staff offered to call 911. Refused. Afebrile. No flu like sx noted by staff other than achy. Dialysis tx given.  D/C to home. Follow-up call made. Pt OK. Went to bed.  11/16/09 Two discharge summaries received, hospital records. Service dates 10/30/09 to 11/10/09. Assessment: Dehydration, swine flu reaction,  Patient presented with fevers, generalized aches, and pains. Very weak and sick. Headache. Non-healing ulcer on right heel. While in hospital became lethargic and difficult to arouse. Developed high fever (105.5), more confused and lethargic. Bradycardic, patient intubated, lost peripheral pulses, resusitation not sucessful, pronounced deceased.  0/04/2010 Death Certificate received. DOD 11/10/2009. Cause of Death: Coronary artery disease, severe peripheral vascular disease, chronic obstructive pulmonary disease, septicemia. Other significant conditions: Status post left below knee amputation, depression, diabetes.
After my second shot, I got a bad reaction or something, or maybe I got COVID-19? I am not sure , all I know is that I was perfectly healthy before I received the 2nd shot ? I started out with feeling like I got out of surgery and into recovery.. Then I got a rash on my arm, I started to have chills, a fever, my words became  Slurred, I got really bad cramps then diarrhea, I have a hard time breathing without coughing, runny nose, sneezing, coughing, just no appetite, and the taste and smell of food is gone , my throat hurts and I am very fatigued no energy st all .. just the feeling of horrible sickness..
Patient stated that she noticed that her skin lightened/discoloration around the injection site area about a week ago. She denies any pain or swelling.
Pt states that there is tingling in the arm she got the vaccine, along with pain below the rib cage.  both started on 2/12/22
Within one day wheezing, severe SOB, severe fatigue, inability to walk without assistance, poor endurance, cognition worsened, confusion
This spontaneous report was received from a nurse who reported that at her office three different unspecified patients lapsed one year between doses of GARDASIL (dose #, route, site of application and lot #s not reported). No adverse effects were noted. Additional information has been requested.
Sudden dizziness after 10 mins. Had sweat a lot for 10-15 minutes. Had a feeling of about to get fainted. Symptoms subsided automatically within 15 minutes without any intervention.
Within 1/2 hour of vaccination, pt c/o feeling nauseous, lightheaded. Place in supine position, legs elevated. BP 96/60. Remained alert, given fluids. Color good. Sent home after seen by MD. Received call from pt in afternoon with additional c/o bad sore throat, strange sensations in legs. Referred to primary care MD who she did see.
This spontaneous report was received from nurse who is also the patient, referring to herself, a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-NOV-2018, the nurse administered a PROQUAD lot # R015739 with expiration date 02-DEC-2019, for prophylaxis to a patient (route of administration was not reported). Other suspect therapies included MERCK STERILE DILUENT lot # R006343 with expiration date 01-DEC-2019 (also reported as "01-DEC-2020"). It was stated that the patient inadvertently kicked the nurse's hand while she was still holding the used syringe of PROQUAD and an small amount of the vaccine that was still in the syringe got in the nurse's eye (exposure via eye contact and accidental exposure to product). The nurse immediately flushed her eye with water. The nurse stated that was a "normal, very small amount" of PROQUAD remaining in the syringe and she believed the patient received a full dose. No adverse effect was reported.
I woke up in the middle of the night extremely dizzy and very nauseous. I barely could walk to the bathroom. I threw up. In the morning, I was dizzy and continued to vomit. Around noon, I went to Urgent Care. I was diagnosed with Vertigo. The doctor gave me a prescription medicine to take.
day after vaccine had head pain (mostly involving sinus area - above eyes, between eyes,  between eyes and ears), back of head/neck pain, all over body aches, light fever, chills, fatigue.  All of those symptoms lasted a full day.  A lesser version of the head pain persists, even as I report.
In the middle of the night I had aches, chills, headache. I woke up the next morning with the majority of those flu-like symptoms. At around 6 pm I had a horrible abdominal pain. At 8 or 9 pm I went to the ER, they did a CAT scan and blood work and they concluded that I had an inflamed kidney. They gave me something for nausea and pain because I started throwing up. The pain stopped and they sent me home and things started going back to normal.
One day after receiving the vaccine, I experienced a  day of fever, chills, muscle aches. This is not my typical response to vaccinations I have received in the past. These symptoms lasted for about 48 hours. I slept and took Tylenol for the symptoms. I also drank hot tea for my symptoms. I completely recovered from my symptoms within 48 hours.
This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013 was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a "heat rash" and mentioned that the patient's family contact the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
chest pain; high blood pressure; generalized muscle soreness; delayed itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (generalized muscle soreness), PRURITUS (delayed itching), HYPERTENSION (high blood pressure) and CHEST PAIN (chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (generalized muscle soreness) and PRURITUS (delayed itching). On 22-Feb-2021, the patient experienced HYPERTENSION (high blood pressure). On 24-Feb-2021, the patient experienced CHEST PAIN (chest pain). At the time of the report, MYALGIA (generalized muscle soreness), PRURITUS (delayed itching), HYPERTENSION (high blood pressure) and CHEST PAIN (chest pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Electrocardiogram: normal Normal.         No Concomitant Medicines were included  Treatment medicines included Isosorbide Mononitrate 20mg which lasted for 3days.  This Friday patient is going to Stress Test
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who have received improperly stored doses of VARIVAX (Merck). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a Licensed Practical Nurse refers to a 68 year old male patient. Patient's concurrent condition included end stage renal disease. The patient's medical history included heart transplant and drug reactions/allergies were none. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (lot number: K001504 with expiry date of 28-MAR-2015) intramuscularly as a part of protocol. Concomitant medications were unknown. On 16-SEP-2014, the patient also began hemodialysis treatment. On 16-SEP-2014, the patient had a headache and experienced crazy dreams. The patient sought medical attention by calling healthcare professional on 19-SEP-2014. The outcome of the events headache and crazy dreams was reported as not recovered/not resolved. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Patient stated that he felt "ill" and "very off." Stomach upset and lightheadedness.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions or allergies reported. On 26-MAR-2018, the patient was vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU (lot # N013278, expiry date 26-JUL-2018), subcutaneously which was reconstituted with properly stored STERILE DILUENT as prophylaxis. The patient was stored at a temperature of -9 degree Celsius to 8 degree Celsius, (6 degree Celsius) for a time frame of 7 days. No previous temperature excursions reported. There was a digital data logger involved. No adverse event was reported. Product quality complaint (PQC) was not involved.
Left side of face started going numb and tingling, jaw hurt and felt still, began rapid breathing and had watery eyes, then left side of body had less sensation
Angioedema in the face; Redness in the face; A spontaneous report was received from a 37 year-old, female, nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema in the face and redness in the face.   The patient had a medical history of allergy to a lot of chemical compounds. No relevant concomitant medications were reported.   On 05 Jan 2021, 48 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026AL20A) intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, 48 hours after receiving the vaccine, the patient started with angioedema and some redness on the skin in her face. She stated it lasted for a complete week.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events angioedema in the face and redness in the face were resolved on 15 Jan 2021.; Reporter's Comments: This case concerns a 37-year-old female patient with relevant medical history of allergy to chemicals who experienced an unexpected medically significant event of Angioedema and an unexpected non-serious event of Erythema. The events occurred approximately 48 hours after receiving first dose of mRNA-1273 (Lot number: 026AL20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Patient's prior history of allergy to chemicals may have been contributory.
Numbness in hands and lips; Numbness in hands and lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 13:15 as dose 1, single (Lot number: HD9876) at the age of 53 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 30Sep2023 as dose 1, single. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin". The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 01Oct2023 at 03:00, outcome "recovering" and all described as "Numbness in hands and lips". Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia oral.  Additional information: Other medications in two weeks included multiple vitamins.
Spiked a high fever (103.4) with sudden onset chills, muscle soreness, headache and fatigue.  Fever reduced after ibuprofen to 102 and persisted for 36 hours.  Extreme fatigue, muscle soreness, sweating and increased urination for 36 hours.  Symptoms have resolved with exception of persistent fatigue and arm soreness
Whole Left arm  pain and heaviness on left shoulder. Unable to raise arm up or behind back and hurt to lie on its side. for 2 days.  Body fatigue and extremities weakness .  Took Advil 200mg  x 1 and rest for 2 days.  Feel better 3rd day.
tinny taste in the back of my mouth; rash on my arm; face was pink; A spontaneous report was received from a consumer, concerning  a 70 years adult female patient, who received Moderna COVID-19 Vaccine and experienced 1 dose.  The patient's medical history was not provided.  The concomitant products was not provided.  On  04-Mar-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: 029AD1A) and route of administration is  unknown route for COVID-19 infection prophylaxis.   The treatment includes that  Patient reports putting Benadryl on her arm today 04Mar2021.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event (Rash,Dysgeusia,Rosacea) was considered to be not resolved at the time of this report.
Myocarditis - Inflammation of heart muscles. (Symptoms: Chest tightness & pain)
Information has been received from an investigator concerning a child who received Pnu-Imune 23 vaccine on 3/11/02, as part of the study, "Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunization in HIV-Infected Children Treated with Highly Active Antiretroviral Therapy." Concomitant vaccine therapy included Prevnar, and MMR II. THe pt's concurrent illness HIV and was treated with highly active antiretroviral therapy. The child developed "grade 3" fever (greater than 103 deg. but less than 105 deg F. as defined per protocol) and "grade 3" pain (severe pain requiring analgesics more than four hours after and/or limiting usual activities as defined per protocol) week 16 of the study. Grade 3 reactions were considered per protocol. The investigator stated that no relationship existed between fever and pain to the administration of MMR II and Prevnar. The investigator considered the fever (expected per local label) "possibly related" and the pain (unexpected per local label" "definitely related" to the administration of Pnu-Imune 23 vaccine.
ED visit, Non-prescription medication, Prescription medication No significant past medical history who presents to the ED with 2-week history of fever, chills, fatigue, sweating and frontal headache.  The patient states that 4 days after getting her Covid Pfizer vaccine//2021 she started developing the symptoms on a daily basis.  The symptoms have been constant with no day/night variations. The patient has been taking Tylenol and Advil with mild improvement in symptoms.  Patient also reports some "swelling" at the side of her neck, but no URI symptoms or problems with swallowing.  She did report also dry cough with no CP, SOB, palp, wheezing, or hemoptysis; On presentation the patient had mild fever 37.9, heart rate 122, BP 80/52, she received 1 L bolus of Plasma-Lyte and pressure responded.  CBC showed mild hypochromic microcytic anemia Hgb 11.3, MCH 25.1, MCV 78.2, platelets 295, no leukocytosis WBC 7.4.  Her metabolic panel showed mild hyponatremia NA 132, K4.7, CR 0.9.  There was mild AST 84 and ALT 69 elevation with normal bilirubin 0.6, alk phos 241.  Lactate x2 normal.  Troponin x1 normal.  Normal coagulation panel.  Negative Covid and respiratory panel.  UA showed SG 1.020, trace ketones, protein, leukocyte Estrace, 1-5 WBC and RBC.  Blood and urine cultures were sent.  Patient was started on Vanco and Zosyn.  Chest x-ray normal. Abdominal ultrasound shows GB wall thickening 6.9 mm, negative sonographic Murphy sign. Mild hydronephrosis of right kidney.. Portal lymph node. Borderline enlarged liver 18.2 cm. Left liver cyst 2.2 x 1.6 x 2.3 cm; Extensive workup was done and patient presented with diagnosis of chronic Hepatitis B and extensive retrorperitoneal lymphadenopathy on CT abdomen. Patient followed by Infectious disease and oncology for differential diagnosis of lymphadenopathy that included infection x lymphoma/leukemia.