chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of a possible allergic reaction in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On an unspecified date, the patient received the fifth dose of Infanrix (lot DTPA586B9). On 4/28/03, at an unspecified time post immunization, the patient experienced a possible allergic reaction characterized by swelling and redness at the injection site. The patient was seen by the physician, who prescribed prednisolone sodium phosphate and cephalexin. The event resolved on 5/3/03. The reporting nurse considered the event was related to vaccination with Infanrix.
Information has been received from a physician concerning a 16 year old female, who on 15-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant suspect vaccination included hepatitis A vaccine (inactive) (MSD) (dose not reported).  A few minutes after receiving Gardasil the patient fainted.  She hit her head during the fall and had to get 3 stitches.  On 15-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Approximately 24 hours after dT booster pt noted muscle aches, malaise, chills.  (Pt did not document his temp.)
began having chills, diarrhea, HA, and body aches at midnight 1/27
Client  presented to the vaccination site on 11/04/2021. The client notified  RN that he received  COVID vaccine on 02/2021 in.  RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the Janssen COVID vaccine. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team. Client received COVID vaccine (Janssen, Lot# 1855194) on 11/04/2021 at 11:37 am. The client did not report any symptoms during the 30 minute observation period.  RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 12:10 pm, walking with steady gait.
This spontaneous report as received from a registered nurse refers to an 18 year old patient of unknown gender. No concurrent conditions or medical history were provided. On 09-DEC-2014, the patient was vaccinated with an adult dose of RECOMBIVAX HB injection administered intramuscularly (strength, dose, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effect was reported. Follow up information has been received from a registered nurse on 11-MAR-2015 refers to a 19 year old female patient with no known allergies who on 09-DEC-2014 received first dose of RECOMBIVAX HB (lot # K011239, expiration date not reported) in the right arm, 1 mL instead of an 0.5 mL dose which was needed for their age of group (Off label use). On the same date on 09-DEC-2014 the patient also received the following vaccines: first dose of GARDASIL (lot # K006191, expiration date not reported) (dose not reported), intramuscular in the left arm; first dose of ADACEL (lot # U5013AA, expiration date not reported) (dose not reported), intramuscular in the right arm; fourth dose of (Vero) IPOL (lot # K1169, expiration date not reported) (dose not reported) subcutaneous in the right arm and first dose of MENVEO (lot # A13051) (dose not reported), intramuscular in the left arm. Additional information is not expected because all follow ups requested to complete the case were received.
Right upper extremity and hand were cold to touch. No change in color. On 2/28/07, pt was vaccinated on 2/28/07 between 415 and 4:30 on 4/28/07. Pt's mother called pediatrician after seen in Er that day given Benadryl at ER. Right extremity on arrival to ER extremity right pink, warm to touch
Patient received the flu-HD and Pneumo shot in her left arm on 09/06/2013. On 9/13/2013 she stopped at the pharmacy that she developed the cellulitis in her left arm and was treated by her MD with KEFLEX 500 mg TID. She is feeling fine.
After receiving  TDAP, HPV, MCV4 vaccines patient began to experience dizziness, weakness, and blurry vision.  VS were obtained at 9:55AM; BP 105/70, O2 95%, HR 54.  Cold pack was applied to back of neck.  Mother stated no prior history of vaccine reactions and no allergies.  Patient showed no signs of improvement; EMS was called at 10:07AM.  Patient stated she was feeling better at 10:15AM.   EMS arrived at 10:20AM, VS retaken O2 100%, HR 90.  Patient was transferred to EMS and discharged.
Crying/screaming for several hours within 2 hrs of receiving injection. (high pitched screaming)
COVID-19 complication; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19 complication) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (Double pneumonia) in 2021, Unable to walk and COVID-19 in 2020. Concurrent medical conditions included Amyotrophic lateral sclerosis.   In March 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 complication) (seriousness criterion death). The patient died on 29-Jun-2022. The reported cause of death was covid-19 complication. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Patient was a healthy person until he caught covid. The patient was passed away due to complications of COVID-19.  The patient had suspected signs of Lou Gehrig's disease in 2021, but did not received the diagnosis untill june 2021.  Company comment:  This is a spontaneous case concerning a 69-year-old, male patient with Amyotrophic lateral sclerosis and COVID-19 one year before first vaccination, who died after the administration of three doses of mRNA-1273 vaccine due to COVID-19 complications. No further information on clinical course, investigations and autopsy was available in the report. Her wife stated that the patient was healthy before COVID-19 disease and died due to COVID-19 complications. The patient died about 15 months after the first dose, but latency could not be assessed in regards of the third dose due to lack of information on vaccination date. The company causality for the event COVID-19 was assessed as not applicable, since mRNA-1273 vaccine is a nucleoside modified vaccine that does not contain any virus capable of causing viral infection. COVID-19 is the confounder of event and patient underlying condition of Amyotrophic lateral sclerosis a risk factor to developed COVID-19 complications. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744264:Wife case; Reported Cause(s) of Death: COVID-19 complication
Chills, 101 fever night one at about 1:30 AM,  treated with Tylenol,  Night two low grade fever 99.7 at 8pm that I treated with Tylenol, Night 3 low grade fever 99.1 again treated with Tylenol.
DATE OF BIRTH WRITTEN AS (UNLISTED) AND AGE WRITTEN AS 12 YEARS OLD ON CONSENT FILLED OUT BY PERSON IDENTIFIED AS FATHER. A REGULATORY AUTHORITY, INDICATES DOB AS (UNLISTED). CHILD IS TOO YOUNG TO RECEIVE SERIES IN 6/2021
fatigue after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue after the second shot). At the time of the report, FATIGUE (fatigue after the second shot) outcome was unknown.            Reporter did not allow further contact
Weakness; Asthenia; Chills; headache; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) injection for Atopic dermatitis and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Rash and Atopic dermatitis. Concomitant products included USTEKINUMAB (STELARA) for an unknown indication.   On 04-Feb-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 18-Feb-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In April 2021, the patient started CERTOLIZUMAB PEGOL (CIMZIA) (unknown route) at an unspecified dose. On 17-Aug-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In August 2021, the patient experienced TREMOR (Shaking). On 30-Aug-2021, the patient experienced ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache). At the time of the report, TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: hemoglobin dropped from 13 to 8.. On an unknown date, Oxygen saturation: Remain stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for Lupus-like syndrome, Haemolytic anaemia, Renal failure, Pulmonary oedema, Angioedema and hospitalization for Haemoglobin decreased experienced prior to moderna vaccine. Pulmonary oedema was treated with Furosemide.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I was told to call this number/because I'm pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F212A) for COVID-19 immunization.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I was told to call this number/because I'm pregnant). On 09-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (I was told to call this number/because I'm pregnant) had resolved.            No concomitant and treatment medication were provided
This spontaneous report was received from a medical assistant via a company representative and refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported) for routine vaccination. Concomitant medications were not reported. On an unknown date, one month after receiving GARDASIL 9, the patient experienced vertigo lasting for an unspecified duration of time. The outcome of vertigo was reported as fully recovered. The relatedness between the event and the vaccine was not reported. Additional information has been requested.
Really bad pain; Can't lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm). At the time of the report, PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.    Reporter did not allow further contact
Next day post vax, the pt developed a fever of 102. Later that evening, the pt's fever raised to 104.6 with seizures. Taken to ER. On 8/25, the pt's temperature came down to 101, child doing better. Physician thought it may have come from the DTAP. He dx with eye infection.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 5/28/2022 Discharge Date: May 31, 2022  PRESENTING PROBLEM: Confusion [R41.0] Weakness [R53.1] Respiratory tract infection due to COVID-19 virus [U07.1, J98.8] COVID-19 [U07.1]   HOSPITAL COURSE: 77 y.o. male with Hx of DM type II, HTN, RA, and OSA who presented with confusion and generalized weakness.   In the emergency department the patient was febrile to 39° C. BP was elevated while in the emergency department. Mg 1.4. Hgb 10.4. COVID PCR was positive. CXR without an acute process.  1 L of IV fluids was given as well as 2 g of IV magnesium sulfate.   Patient stayed in hospital for approximately 3 days. Patient had remained stable throughout hospital stay. His electrolyte imbalances were all corrected after the 1st 24 hours of stay. Patient's confusion also had resolved. Dr. assess him initially and recommended skilled nursing facility.  On subsequent days he has strength significantly improved that with reassessment recommendations had changed to home with home health.  And with patient stable he was then discharged home on 5/31/2022.
Rash over arms, around breast and upper stomach, armpits, and injection site.  Rash lasted about 3 days.  Other effects were nausea and headache.
patient fainted on the chair eyes rolled back her arms and legs tensed up and she started having a seizure.  Patient was slouched out of the chair, halfway on the ground, stiffened arm and eyes rolled back in her head. She was lowered down to the ground where she had witnessed tonic-clonic seizure activity for approximately 5-10 seconds. She then woke up screaming/crying and was in a postictal state until EMS arrived, about 10minutes. Patient was given a couple sips of water as she remained stable, sitting calmly in the chair. Vitals and fingerstick for BGL was taking by nurse. MA and nurse sat with patient until EMS arrived.
Fatigue extreme; Joint pain; Hot flashes; Chills; Soreness at shot side; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to lactose (Food allergy). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 04Mar2021 at 16:00 (at the age of 56-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 23:00, the patient experienced fatigue extreme, joint pain, hot flashes, chills and soreness at shot side. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue extreme, joint pain, hot flashes, chills and injection site pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Felt tight on the chest, racing and pounding, flittering of heart, short of breath. I saw a cardiologist. He prescribed a patch monitor for 15 days on 10/4/2021. No treatment. Feeling better now.
muscle cramping; that keeps him awake at night; posterior leg pain; muscle pain/muscle aching; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (muscle cramping), INSOMNIA (that keeps him awake at night), PAIN IN EXTREMITY (posterior leg pain), FATIGUE (fatigue) and MYALGIA (muscle pain/muscle aching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (fatigue). On 12-Mar-2021, the patient experienced MUSCLE SPASMS (muscle cramping), INSOMNIA (that keeps him awake at night), PAIN IN EXTREMITY (posterior leg pain) and MYALGIA (muscle pain/muscle aching). At the time of the report, MUSCLE SPASMS (muscle cramping), INSOMNIA (that keeps him awake at night), PAIN IN EXTREMITY (posterior leg pain) and MYALGIA (muscle pain/muscle aching) had not resolved and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.
Reaction/Event: developed fever as high as 101.3F. Case Narrative: Upon second medical examination of the case at the time of internal review changed has been done in subject screen, product screen and removed event "irritability" and updated Core Unlisted for screaming in event screen. Changed has been completed in assessment screen and company narrative as per instructions. Initial unsolicited report received from a non-healthcare professional (patient's parent) on 8 October 2015. This case involves a (2-month-old) male patient who was vaccinated with a [route and dose series not reported] dose of ACTHIB (batch number UI376AA, expiry date and site of administration were not reported), received a dose of PEDIARIX (manufacturer GSK , batch number, expiry date and site of administration were not reported), received a dose of PREVNAR (manufacturer PFIZER , batch number, expiry date and site of administration were not reported) and also received a dose of ROTAVIRUS VACCINE (manufacturer other , batch number, expiry date and site of administration were not reported) all vaccines administered on 7 October 2015 (10:00 AM). Patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications was not reported. On 7 October 2015, patient had developed fever as high as 101.3 Fahrenheit. It was reported that, patient continues to run fever 24 hours later and had shakiness and screaming. Laboratory investigation and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none. Addendum: 07 Jan 2016, Upon second medical examination of the case at the time of internal review changed has been done in subject screen, product screen and removed event "irritability" and updated Core Unlisted for screaming in event screen. Changed has been completed in assessment screen and company narrative as per instructions.
Left thigh red size 5 by 4 centimeter-per treat with warm cool compress and apply cultivate cream to area (thigh) twice a day.
-arm very sore -severe tingling like electric current -extreme swelling at injection site -arm very hot to the touch -itching -arm spasms -pain -large lump under skin at injection site
started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; This is a spontaneous report from a contactable consumer. A 40-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Apr2021 (age 40-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started to develop bumps on his legs and then it had morphed into basically IGA vasculitis on 19Apr2021. The patient said that he was told that when he called, he was supposed to reference a case number, that was opened by his dad. He provided that he did not know how much information was on that original case but basically on 13Apr2021 he had the first dose of the COVID vaccine and then on 19Apr2021 he started to develop bumps on his legs and then it had morphed into basically IGA vasculitis. He asked how long a safety report took and he was just trying to follow up on what his dad had already started. He was hoping that he could just get some information and feedback on the correlation of getting the COVID vaccine and cases of IGA vasculitis. He said if he could be given answers to his question as opposed to going through with a report then he would rather go to that department. The reason for no lot number of COVID vaccine, was that the caller was unwilling to complete the report. The outcome of the events was reported as unknown.
Seems like ringing in ears (possibly tinnitus). Some occasionally pulsating in ear mostly ringing
1/24/21 0445- patient presents to the ED with complaints of  neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE.  Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen.  1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large  brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci  in clusters growing after 9 hours.
decreased vision and pain with extraocular eye movements on left eye with associated afferent pupillary defect, decreased color vision, optic nerve edema