chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included 2 co-morbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
Employee initially  c/o headache, body ache but 2 days later developed SOB and was hospitalized for 2 days.
9/17/98 - Received first anthrax injection. 10/01/98 - Received second injection. 10/15/98 Received third injection. 3/17/99 received fourth injection. 9/29/99 received 5th injection. 3/27/00 received 6th injection. October 1998 - started crying for no reason with feelings of worthlessness. Started having sleepless nights. 2/8/99 diagnosed with major depression by psychiatrist and prescribed Prozac and Ativan. Medication changes throughout the term of care. Used Zoloft, Effexor with small amounts of Buspar. Tried several anti-anxiety medications. Klonopin, Xanax, Ativan. 6/26/02 suicide attempt using large amounts of Xanax and Klonopin. 7/26/02 current medications--Remeron 30 mg taken at bedtime. Ritalin 5mg taken in the morning. Inderal 2.5mg taken as needed. Review of hospital discharge summary and medical records verifies diagnoses currently COSTARTED. Please add diagnosis of anxiety.
On June 4th 2021 I awakened in the morning with a dry and sore throat. I thought I had maybe been sleeping with my mouth open, it dissipated when I got up and walked around etc. The next morning, I woke up again with the sore throat but when I coughed it really hurt and was a deep rumble in my throat. My roommate said it sounded like I had Bronchitis. My roommate had just had Bronchitis for several weeks. A few hours later, on 6/5/2021, I had a deep rumbly cough that continued and I went to the Urgent Care on 6/6/2021 and they examined me. They found I had bad Bronchitis and possibly even dry Pneumonia. They looked to find out what they could treat me with, I was also being treated for a tick bite that had happened a few weeks before. They did flu and Covid tests. They treated me with something that would treat for Lyme disease as well as the Bronchitis. They found that the treatment of Doxycycline Hyclate 100MG capsules of three weeks regimen would help both my problems. It took at least a week for the cough to die down and then another couple of weeks before the cough disappears.
Date of Admission: 10/19/2022   Date of Discharge: 10/27/2022   Admission Diagnosis: GI bleed  Gastrointestinal hemorrhage    Hospital Principal Problem (Discharge Diagnoses): Genitourinary bleeding
On 12/19/2016 patient received PNEUMOVAX23 and FLUCELVAX immunizations in his left arm. Received BOOSTRIX in his right arm. Patient's wife called 12/22/16 stating that he was having a fever ranging from 99-100.8. And his left arm was feeling sore, along with redness and swelling on the front side of the arm. She said he was feeling better today than yesterday, but wanted to check in. I told her that these are typical side effects of vaccinations and I recommended taking ibuprofen to help with symptoms. If the symptoms did not get better then he could come in and we could look at his arm, or he could go to the doctor.
Temperature of 98.8, right upper arm discomfort a few hours post injection. Patient took Ibuprofen and went to sleep. Reported to clinic 9:50 AM on 01/19/05, ice cap applied after reporting to doctor regarding right upper arm edematous, warm to touch and red, given Ibuprofen 600mg at 9:55 AM, Benadryl 25mg PRN. Just treated and discharged.
Cant lift my arm; Extreme pain under my arm; Stomach pain; Body ache; Starting to get a temp; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 05Jan2022 at 15:45 (Lot number: unknown) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Hbp and "High cholesterol" (unspecified if ongoing), notes: slightly high cholesterol. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm), administration date: an unknown date in Apr2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm, Administration time: 16:45), administration date: an unknown date in May2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 15:45, outcome "unknown", described as "Dose received: 3"; MOBILITY DECREASED (non-serious) with onset 05Jan2022 at 22:00, outcome "not recovered", described as "Cant lift my arm"; AXILLARY PAIN (non-serious) with onset 05Jan2022 at 22:00, outcome "not recovered", described as "Extreme pain under my arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Jan2022 at 22:00, outcome "not recovered", described as "Stomach pain"; PAIN (non-serious) with onset 05Jan2022 at 22:00, outcome "not recovered", described as "Body ache"; BODY TEMPERATURE INCREASED (non-serious) with onset 05Jan2022 at 22:00, outcome "not recovered", described as "Starting to get a temp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of mobility decreased, axillary pain, abdominal pain upper, pain and body temperature increased.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever 36-48 hours  Headache  Chills Nausea  Aches/ sore muscles
Mother appears at the vaccination center on Monday, march 6 at 10:28am to notify that the patient got rash in the area of the mouth on Saturday, march 4 at 9:00pm indicates that he will take it to his pediatrician, Dr.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 007C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
5/25/04. Telephone call from child's mom. States child has temp of 103 degrees & pulling at ears. No other complaints. Advised to call PMD and give Tylenol. 5/26/04 telephone call from child's mom-states child had seizure after talking to nurse yesterday. Was seen in ER. Had spinal tap and blood work done- Doctor said febrile seizure. Child ok at this time. 6/2/04 telephone call to child's mom- states doing fine.
Patient had a flu shot 1 week ago and is still experiencing major pain in her clavicle area and cannot lift her arm. The pain is not subsiding, but not getting worse. Ibuprofen helps slightly. I referred her to her doctor.
On 1/5, developed fever 101 F, chills, Headache, back ache, and throbbing pain left arm
A nurse reported that a pt did not respond to the hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) immunization series. the pt had no medical history or illnesses. Concurrent medication were not provided. The pt rec'd injections of Twinrix on 2/8/02, 3/12/02, and 8/27/02 (lot#HAB568A4). On 11/25/02, 3 months after the last injection of Twinrix, titers for hepatitis A (NOS), hepatitis B surface antigen, hepatitis B surface antibody, and hepatitis B core antigen IgM were negative.
Pt's birthdate was given incorrectly, and pt received the vaccine before this was realized. No adverse event ocurred, this was just administered too soon (pt not 16 years old at time of vaccination).
Low grade fever, stiffness in RUA, erythematous non-puritic rash on RUA. No weakness in BUE. Full ROM to RUE. Provided with ALEVE PRN, apply ice to RUA.
Body Aches, Fever, Chills, Hot Flashes, Thirst, Lethargy, No Appetite. On April 19, 2022- I slept 21 hours.  Fever at 100.2, Lethargy, unsettled stomach, soreness at the injection site on April 20, 2022
Fever over 102°F; Chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever over 102°F) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Asthma and Lyme disease.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (Fever over 102°F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever over 102°F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 102 (High) 102 degree Fahrenheit. On 26-Jan-2021, COVID-19: positive (Positive) POSITIVE.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-014845:Same reporter (female Patient's case)
Rt anterior thigh has 3" diameter red circle that is swollen and warm to touch. No systemic signs and symptoms (i.e. fever) but is "favoring" right leg. Ambulates "fine". This leg received DTAP. Left anterior thigh has the same signs and symptoms but to a much lesser degree without any problems.
Started with scant itching to site 12/28,  developed large 4in x 4in inflamed site to L arm injection site, red spot hot to touch, tender and scantly itchy. Redness resolved in 3 days but arm continues to itch.
Covid + on 10/29/2021. Received Pfizer vaccine with 1st dose on 04/01/2021 LOT #EW0150 and 2nd dose on 04/22/2021 LOT# EW0164 Patient was admitted to in patient behavioral health unit on 10/21/2021. Tested positive on 10/29/2021 and transferred to inpatient acute care.
C/O cough, chills, throat closing up, sore throat, eye drng, blood shot eyes, possible fever. Was taking Tylenol for symptoms. No local site reaction reported.
HYPOTENSION 3/21/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Received on shot on 1/15/21.  On 1/23/21 at the injection site it started itching.  When she looked it was a small, red area.  Slightly warm and felt hard. Does not hurt without touching it.  Did circle the redness to watch this area.  Redness stayed pretty much within the circle, but expanded out on one side.  Today on 1/25/21 it looks "fine."  The coloring is fading. Less red, more light pink.  Not warm. No itching today either.
pt recv vax 9MAY96 & 10APR96 pt lt arm became red & very swollen;By 13MAY96 pt sx had mostly resolved;
Mother stated that child's hands and feet began peeling on 5/14/18. The child received vaccines on 5/4/18. She stated the child is healthy and the vaccinations had to be the cause of the peeling extremities. Mother stated that child was taken to a local nurse practitioner office and given steroid cream. The steroid cream has helped with the peeling. Mother requested VAERS form to be completed.
lymph nodes in underarm are swollen and painful; lymph nodes in underarm are swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "lymph nodes in underarm are swollen and painful".  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a other health professional and described the occurrence of vomiting in a patient who received BEXSERO (batch number 16D301, expiry date February 2019). On an unknown date, the patient received BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional details were provided as follows: This case was reported by the Medical Assistant. The age at the vaccination was not reported. On Monday at 3:30 pm, the patient was administered BEXSERO. The patient had to be picked up from school on Tuesday morning with bad vomiting. The physician believed this might be the 3rd or 4th patient that has had vomiting after receiving a BEXSERO dose since July 2017.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 04-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This case is one of several received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Swelling of the armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling of the armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling of the armpit). At the time of the report, SWELLING (Swelling of the armpit) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
experienced high Fever; chills; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: experienced high Fever) and chills (Verbatim: chills).  The outcome of the fever and chills were not reported.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     It was unknown if the company considered the fever and chills to be related to Shingrix.   Additional Information: GSK receipt date: 14-Sept-2023 The patient received a dose of Shingrix and experienced high fever and chills. Rest unknown. The reporter did not consent to follow-up. The case was linked with case US2023AMR128148, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR128148:same reporter, same drug
This spontaneous case was initially received on 23-Sep 2015. The case report was received from a Health Professional and concerns a 62 year old female patient. The patient has a medical history of Diverticulitis and Colitis. The patient received AFLURIA on 21-Sep-2015, Batch no: U55006, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left deltoid. No additional drugs suspected. On Sep-2015, after starting treatment with AFLURIA the patient experienced Injection site tender and painful. On 21-Sep-2015, after starting treatment with AFLURIA the patient experienced Arm got hard to touch, Mark about 3 inches round [and hot when I touch it] (injection site), Arm is also red, [Mark about 3 inches round and] hot when I touch it (injection site) /Hot injection site, Hard injection site, Left arm is itchy, Itchy at injection site. The patient has received a flu shot before but is unsure if it was AFLURIA. The patient missed last year's flu shot but has gotten it the 2 years previous. This is the first time she has had a reaction like this. Reporter's assessment: Non serious.
Narrative: 70 yo M with significant PMHx chronic pain, TBI, MDD, seizure, COPD, HTN, CAD, BPH, chronic pancreatitis; received dose #1 of the Moderna COVID-19 vaccine on 3/3/2021 (Lot#: 011A21A; Exp Date: 8/16/2021) around 10:30. Patient contacted facility on 3/4/2021 to report "welts" on bilateral arms. Pt reports he has previously gotten welts for years, in the same area he typically experiences when he has some type of allergic reaction and occurs typically with fruits and vegetables. Patient doesn't feel this outbreak is related to the COVID-19 vaccine. Negative screen for COVID-19 risk factors Patient states he has been seeing community allergist with no specific diagnosis. Pt subsequently reported to ED on 3/12/21 for sharp/lancinating pain in mid-epigastric region and discharged. Pt returned to ED on 3/14/21 for ongoing abdominal pain and chest pain, admitted and hospitalized 3/14-3/15/21 for chest pain, elevated troponins, hypertensive emergency, chronic pancreatitis, transaminitis, and CKD. Cardiac workup negative and his chest pain is most likely related to GI symptoms. Pt subsequently seen again in ED on 3/22/21 for LLQ abdominal pain and undergoing treatment and evaluation of acute on chronic kidney injury, and bloody diarrhea. Admitted 3/22/21 and discharged 3/23/21. Reaction classified as severe as hospitalization required.
PHN called to post vac observation by RN. A 17 yo male Pt stood up during observation to move chairs passing out falling to the floor.  Pt received the 1st dose Pfizer #ER8732 in L arm.  911 called, client placed supine on cot, Vitals 126/77, P:82, O2 98%, Glu 114.  No Hx of illness/med.  Client co dizziness as he stood up prior to passing out. Respirations were observed as non-laborious, rise and fall of chest was visible, WNL.  Pt ambulatory after additional 15 min in sitting position, and DC home with his mother & given education.
I little soreness in my arm after receiving the vaccine for about a day.  I had nasal congestion starting on 11/30/2022. I tested positive for COVID-19 on 12/01/2022 with a home test.  I contacted my doctor, and I was set up with a virtual appointment on 12/02/2022 and I was prescribed Paxlovid. I tolerated the medication with no problems.
Around April 1 I stopped being able to lift my right foot. I had an MRI that came back clear for brain bleeds, but I have fallen and remain a fall risk. It is very difficult to keep my balance and cannot pick up my foot still. I was fitted for a leg brace, which I will hopefully get in the next three weeks.