chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son had a seizure less than 48 hours after his 4 month DPT vaccine. He was hospitalized and continues to have seizures to this day. The medical record states Kleinelter's syndrome and neurodegenerative disorder. My son still has seizures on a daily basis. He is developmentally delayed. His immune system is damaged. He has heavy metal toxicity due to these vaccines CDPT- from the thimersol. He does not live a normal childhood and hasn't since the age of 4 months and lost his identical twin due to these vaccines.
"every single muscle, bone, and fiber hurts in my body" ,  up and down all night,  Arm is swollen and really sore
Information has been received from a registered nurse referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9 (lot # M009378 with expiration date of 23-APR-2018, lot # M013636 with expiration date of 15-FEB-2018, dose and route unknown). The vaccines were exposed to 55 Fahrenheit (F) for 24 hours, 49 F for 24 hours, and 49.6 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd vax & exp fatigue & stiff arm; 1 day p/the 2nd dose exp lymphadenopathy & again a stiff arm;
dizziness; blurred vision; shaky; unable to talk on the phone; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LITHIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Toxicity to various agents: 1.7 (High) 1.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-Jul-2021 included no new information.
Pfizer-BioNTech COVID- 19 Vaccine  Moderna COVID- 19 Vaccine   Patient received COVID-19 Vaccine dose #1 as Pfizer on January 18, 2021 and dose #2 as Moderna on February 11, 2021.
Patient states of numbness and tingling of both lips and warmth in abdominal area. Patient states she is anxious. Vital signs checked multiple times initial was 15 minutes after vaccine administrations BP150/83 P 85 O298 R20  vitals about  20 min later BP 151/82 P82 r 20. Patient observed for 60minutes  and all symptoms disappeared denies blurred vision , and shortness of breath.and all other symptoms.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately 2016 (reported as: on or about 2016), the patient was inoculated with ZOSTAVAX (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries. On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. On or about 2016, the patient was treated for shingles. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Fluzone HD and Fluzone Quadrivalent vaccines were administered subcutaneously, no AE; Based on additional information received on 14-Oct-2020, this case became medically confirmed.  Initial and follow up information regarding an unsolicited non-valid non-serious case received from a non-healthcare professional via Agency (Reference number- 00313623 and 00315619) and transmitted to Sanofi on 13-Oct-2020 and 28-Oct-2020.  This case involves patients who received 0.7 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (batch number LUJ453AB and expiry date 30-JUN-2020) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via subcutaneous route at the back of the arm instead of deltoid muscle for prophylactic vaccination (Incorrect route of product administration).  Medical history, past medical treatment(s), vaccination(s), and family history were not provided. No concomitant medication was given.  This was an actual medication error case due to inappropriate route of vaccination (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.     There will be no information on the batch number for Fluzone Quadrivalent.  Follow up information regarding an unsolicited valid non-serious case received from a healthcare professional via The Agency (Reference number- 00316089) and transmitted to Sanofi on 14-OCT-2020.  Case validity updated and case become medically confirmed.  Batch number, dosing details and expiry date for Fluzone HD Quadrivalent added.  Narrative updated.
Patient received Bexsero Vaccine in right arm. Aferwards, patient then received Varivax in Right arm as well. Prior to vaccinating other arm, patient asked me to wait, because he started feeling a little dizzy. After a couple of minutes has passed, patient reported to me that he cannot see well, but he can still hear my clearly. Patient described vision as "TV Static" and "Blurry and Black". After a few more minutes, patient started to lean in chair and fainted. I was able to catch patient and continue to stay with him the entire time. Patient's eyes were dilated and they were rolled back when he fainted. Syncope lasted about 30 seconds before patient came back. Patient was still having vision issues upon coming back, yet he was able to respond to sound to me. I gave patient water, since he was feeling thirsty, but he was also feeling like he was sweating and had some stomach pains. EMS was called and they arrived shortly and took over from here.
Around 31 hours post booster shot, I woke up with very swollen lips and right eye.  The area above lips is a bit tingly - front teeth a little sore.  Right eye very swollen.    No new meds, no new foods, no new topicals.
Patient monitored for 15minutes post dose with no issues, but later reported she had tingling in her head and both arms within a few hours of receiving the vaccine.  Stated that neither symptom caused her any issues and symptoms resolved within a few hours
Broken hip; Had an accident; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Broken hip) (seriousness criterion medically significant) and ACCIDENT (Had an accident). At the time of the report, HIP FRACTURE (Broken hip) and ACCIDENT (Had an accident) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.  Patient had an accident and because of these accident, patient broke hip and was not able to receive the booster dose of the Moderna COVID 19 Vaccine. Patient wanted to know if after all this time she can still receive the first booster dose of the Moderna COVID 19 vaccine.  Company comment: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, serious (medically significant) event of Hip fracture, unspecified days after receiving a dose of mRNA-1273 vaccine. The patient had an accident which caused a broken hip. The patient reported missing her first booster dose of mRNA-1273 vaccine due to the event. Clinical course and treatment details are not available in this report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, serious (medically significant) event of Hip fracture, unspecified days after receiving a dose of mRNA-1273 vaccine. The patient had an accident which caused a broken hip. The patient reported missing her first booster dose of mRNA-1273 vaccine due to the event. Clinical course and treatment details are not available in this report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Swelling, redness, and tenderness at injection site 2 days after injection  was given.
I95.9 HYPOTENSION 2/22/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 2/24/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 2/22/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 2/24/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE I95.9 HYPOTENSION 2/22/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 2/24/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
CHIEF COMPLAINT:   States that he had covid symptoms starting 5 days ago. Had a positive home covid test on Friday. Has been feeling weak. tonight lowered himself to the floor.
Information has been received from a licensed practical nurse concerning a 65 years old female patient, who on 21-SEP-2012 (today) was vaccinated with expired dose of (Merck) VARIVAX 0.5 ml subcutaneously at left upper arm (Lot # reported as H011553, Exp: 14-JUN-2011 - in validation process). No adverse effects reported. Additional information has been requested.
Severe, debilitating headaches beginning 6 days after injection.  Headaches have been occurring intermittently, and now are less intense but longer in duration.  No prior history of headaches.  Also, arthritis of the right wrist and thumb joints began 2 days after injection and have remained persistent.
8/22 - noted discrete pairs of flat small pink dots above left knee. Over the next few days, more appeared. Ones previously present became larger and redder. 8/29 - Noted more spots on left leg below as well as above knee and appearance of new spots above right knee. 8/30 - Spots appeared below both knees. Redder and now elevated. No itching or pain.
Sore throat, difficulty swallowing, hoarseness and laryngitis. Told to stop VIVOTIF and use ADVIL. Throat culture pending.
gave immunization, patient sat in chair for the 15 mins, wife called for help because pt not breathing,  I administered epipen 0.3, called ambulance, applied ice on wrists, ambulance arrived
Disoriented; Dizziness; No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) had not resolved.            No relevant concomitant medications were reported.
muscle soreness in the arm; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 08-Dec-2020.  This case involved a patient with unknown demographics who experienced muscle soreness in the arm (Myalgia), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (other dosing details unknown) produced by unknown manufacturer lot number not reported.  On an unknown date (latency unknown) The patient experienced muscle soreness in the arm (Myalgia) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The patient had recovered from the event on the same day.  There will be no information available on the batch number for this case.
Body aches; Balance issues; Fever; Nausea; Joint pain; Tired; Headache; Dizziness; Arm pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Jul2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included TBI (traumatic brain injury), hypertension and anxiety. The patient had known allergies to fish oil and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Jul2021 at 22:45, the patient experienced fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site. 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, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site were not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Site of injection is itchy; Area is kind of reddish more like pinkish towards inner arm above and down the site of injection; Pain at site of injection on the same day, still hurting at site of injection; A spontaneous report was received from a consumer concerning herself, a 65-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced VACCINATION SITE PRURITUS  (site of injection was itchy ), VACCINATION SITE PAIN  (pain at site of injection on the same day, still hurting at site of injection) and VACCINATION SITE ERYTHEMA  (area is kind of reddish more like pinkish towards inner arm above and down the site of injection)  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient experienced pain at the site of injection. On the same day she got relieved from the pain when she applied cold compression over that area.  On 13 Jan 2021, at mid night the patient felt like a mosquito bite and then noticed that the site of injection was itchy with a kind of reddish more like pinkish towards inner arm above and down the site of injection towards her breast and experienced a lot of pain. She also tried using cold pack, patient noted that it still hurting. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, site of injection was itchy, area is kind of reddish more like pinkish towards inner arm above and down the site of injection, was considered as unknown. The outcome of the event, pain at site of injection on the same day, still hurting at site of injection, was not recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately 15 minutes after injection I became itchy; the itchiness covered my body from the top of my head to just above my knees. About 5 minutes after that my face became tingly and my breathing became shallow. At this time my blood pressure, pulse ox and pulse were taken. They were all normal, however my breathing was still labored. I used my rescue inhaler, was given a double dose of allergy medicine and 800mg of ibuprofen. Within a couple of minutes my breathing had returned to normal.  Approximately 20 hours after injection I suffered from a headache that lasted around 6 hours. I also became very tired; the day of the injection I slept 10 hours and the following day I slept 12 hours. On both occasions I woke up to an alarm, so I have no idea how long I would have slept on my own accord.  Final thing to note which may not be related, but merely a coincidence: since receiving the vaccine, I have been unusually thirsty.
Dose was given too early in series  (first dose given 8/2/22.  Was not due for second dose until 9/2 /22.     Pt did not exhibit any  symptoms of adverse reaction.
This health care professional reported the same event for 2 patients. This is the first of two reports. This is a spontaneous report from a contactable health care professional (HCP). A 15-month-old male patient received PREVNAR) lot number N47827, expiration date Nov2017), via an unspecified route of administration, in the left thigh, on 26Oct2016, as single dose for immunization. The patient's medical history was not reported. Concomitant medication included varicella zoster vaccine (TRADE NAME UNSPECIFED, Lot number N47827, expiration date May2018), in the left arm as single dose for immunization. The patient previously received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), as first dose, lot number M51192, expiration date May2017, on 05Feb2016 in the right thigh for immunization and experienced no adverse reaction. On 28Oct2016, the patient experienced 5x5 raised hot mark on thigh. The patient visited a physician office due to event. The outcome of 5x5 raised hot mark on thigh was not recovered at the time of reporting on 02Nov2016.; Sender's Comments: Linked Report(s): US-PFIZER INC-2016512480 Same reporter, same drug, same event, different patient.
she reported to have venous insufficiency in her hands, describing that the blood comes into the hands but doesn't go back up; and that it is related to de vaccine. This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL VENOUS DISEASE (non-serious), outcome "unknown", described as "she reported to have venous insufficiency in her hands, describing that the blood comes into the hands but doesn't go back up; and that it is related to de vaccine.".  Additional information: Caller was a dentist reached as a consumer in order to report an AE regarding Pfizer COVID-19 Vaccine. She reported to have venous insufficiency in her hands, described that the blood comes into the hands but doesn't go back up, and that it was related to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.