chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report A0375497A describes the occurrence of learning disabilities in a male child of unspecified age who received hepatitis B vaccine recombinant. This report was received as part of litigation preceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the child received his second and third injections of Engerix B (lot ENG2418A2 and ENG2710A2). He also received DTaP (Acel-Immune), and Haemophilus influenzae type b conjugate vaccine (Hib-Titer). The child's attorney alleged that "The highly toxic emissions of certain power production facilities in the environmental zone of the Plaintiff's residence contributed to the Plaintiff's total dose of poisonous mercury.  Because of Plaintiff's heightened vulnerability to heavy metals poisoning and his compromised condition related to the mercury poisoning discussed above, he was and is unable to process heavy metals and suffers neurological compromise as a result of the heavy metals contributed by the fossil-fuel burning utilities. His impaired condition is compounded by these exposures and his injury is made worse by them. The Plaintiff was poisoned by the cumulative doses of mercury in the environment and, as a result, the Plaintiff now suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning." The attorney further alleged that "After being injected with Thimerosal and inhaling mercury-contained emissions. He had the following symptoms: severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. His problems are caused by Thimerosal and the mercury and/or other heavy metal contained therein." The "severe" learning disabilities, impairments in social relatedness, language difficulties, communication difficulties, and mercury poisoning in this report are considered medically serious.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 20-SEP-2016 (reported as "six days after the vaccine had expired"), the patient was inadvertently vaccinated with a dose of expired M-M-R II (expiration date 14-SEP-2016, dose and lot# were not reported) subcutaneously. No apparent adverse effects were reported. Additional information has been requested.
Left arm injection site is warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm injection site is warm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Left arm injection site is warm). At the time of the report, VACCINATION SITE WARMTH (Left arm injection site is warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Erythema, induration measuring 3.25 inches from 12 decreased 6 and 5 inches from 9 - 3 on the face of a clock. Temp 100.2 orally. Tylenol alternately with Ibuprofin. Cool compress prn.
7 days after shot the injection site became swollen, very sore, the red circle around injection got more pronounced and the site because very itchy. This lasted for about 48 hours. There is still a red mark today, but swelling, pain and itchyness have all gone away.
This non-serious spontaneous case, initially received on 01-Oct-2018, combinedly processed with the follow-up IRD 03-Oct-2018, from other non-health professional (consumer), concerns a female pregnant patient of unspecified age. On an unspecified date, the pregnant patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. At the time of this report, the patient did not experience any adverse event.
8:00am on 12/31/22: Nausea, cold and hot chills, major body aches, diarrhoea,  vomiting , fatigue, weakness so that I could barely shower, swollen lymph nodes in right side of neck.   Persistent nausea as of 3:20pm on 1/2/23; some diarrhoea,  itching at injection site,  break into cold sweats at slightest exertion including getting out of shower; have to change clothes several times a day.
it made her arthritis flare up.  She was having issues breathing and catching her breath.  She had swelling and a rash, weakness, pain and the worse is she passed away on Sunday July 25, 2021.
This study report as received from a consumer, as part of a marketing research, refers to her daughter of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, lot # and route were not reported). On an unknown date the patient's entire body broke out and she felt terrible for several weeks. The reporter thought this was really scary. At the time of this report, the outcome of the events was unknown. Causality was not reported. Additional information is not expected as the reporter does not wish the doctor to be contacted.
Information has been received from a 23 year old female with no drug reactions/allergies and no medical history who on 29-MAR-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscularly. There was no concomitant medication. On 29-MAR-2007 the patient fainted after receiving the first dose of the Gardasil. The patient sought unspecified medical attention. On 29-MAR-2007, the patient recovered from fainting. Additional information is not expected. Information has been received from a registered nurse concerning a 23 year old female with no pertinent medical history who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular administration.  Concomitant therapy included VALTREX.  Subsequently, the patient fainted after receiving her initial dose of GARDASIL and recovered that same day.  The nurse reported that the GARDASIL was improperly stored at room temperature for three weeks prior to use (approximately 07-MAR-2007).  Approximately two months later (28-MAY-2007) the patient received her second dose of GARDASIL.  It was reported that the patient's second dose had been stored at room temperature for five days prior to use (approximately 23-MAY-2007).  Product Quality Control (PQC) was not involved.  Additional information has been requested.
Muscles aches -generalized - onset within 2 hrs nausea abdominal cramping - 3 days reflux. H/A , fatigue - 2 1/2 weeks (mouth ulcers, blisters,, gone gums tongue , metallic taste  mouth bilateral taste) 2 1/2 - 3 weeks nasal pharageal limitation (feel like either inside of body on fire
I have been ill 9 times since receiving 2nd shot after a lifetime of exceptional general health. Symptoms include recurrent fever, muscle soreness usually occurring in both legs, general malaise, severe fatigue, chest tightness, and mild fever.
Information has been received from a LPN concerning an 18year old female with no pertinent medical history and no prior drug reactions who on 21-FEB-2007 was vaccinated with second dose Gardasil (Lot#653978/955F). Concomitant therapy included ORTHO TRI-CYCLEN and BENADRYL as needed for rash/itch. The patient was administered her first and second dose of Gardasil via the gluteus. The first dose was administered at another practice (not administered by the reporting nurse's practice). On 12-FEB_2007, the patient received her second dose of Gardasil and within minutes of vaccination, she experienced dizziness. Subsequently, after a few minutes, the patient recovered from dizziness. The patient sought unspecified medical attention. Additional information has been requested.
tinnitus rt. side dominant. beginning < 7 days after last dose; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, at age 60 years, administered in right arm on 18Feb2021 15:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. No other vaccine in four weeks and no other medications in two weeks. Patient historically took first dose of BNT162B2 on 28Jan2021 03:30 AM, on the right arm at age 60 years for COVID-19 immunisation. On 23Feb2021, the patient experienced tinnitus rt. side dominant. beginning < 7 days after last dose and ongoing to date. Therapeutic measures were taken as a result of tinnitus includes offer of biotherapy. AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 13Apr2021 (post-vaccination). Facility type vaccine was other. The outcome was not recovered.   Information about lot/batch number has been requested.
After suffering from sudden extreme fatigue and the worst headache of my life,  I fainted/passed out cold on the floor.  In my 56 years, I have NEVER experienced anything like this before.
Spoke with patient today. He experienced severe flu like symptoms approximately 4 to 6 hours after the vaccination. He had a severe headache. fever of 104 along with chills that lasted 1 days followed by extreme heat  Patient also expressed to me that he suffered from shortness of breath that lasted about 12 hours during time of high fever. followed by aches and pains lasting about 2 days.
This study case was received from the investigator on 05 February 2013. A 31-year-old male subject received an injection of ACAM2000 (lot number not reported) on 31 October 2012. The subject has no significant medical history. On 12 November 2012, the subject was diagnosed with Other, chest pain. Diagnostic testing on 15 November 2012 included: normal Troponin I, abnormal ECG, normal echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.
face was hot, dizziness, loss of appetite, light headed and having horrible migraines has been affecting everyday routine
Low grade fever (100.4) for a day with rash (looks like Measles rash) for a week.
Information has been received from a physician concerning a 17 year old female, who, on an unspecified date, was vaccinated with a 0.5mL first dose of Gardasil.  Subsequently, the patient experienced severe joint pain.  The patient sought unspecified medical attention.  A serum antinuclear antibodies test was performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Beyond the common side-effects, which I experienced for one week, I also had shortness of breath for about two weeks. My chest/lungs just felt tight. It wasn't a heart attack. It was just as if I couldn't get a full breath as I normally would and I felt winded.   Please note that I am NOT a smoker and I don't have any underlying health issues. I exercise frequently and eat healthy.
8 days after first dose of Moderna vaccine, developed two red spots on upper left arm slightly below injection site. They were hot and red and tender to the touch. Flesh also felt somewhat hard/firm in that area. It hurt to move my arm. Took photo in the morning, and two hours later the spots had almost doubled in size, coming together as one larger red area that eventually covered most of my upper, outer arm. By the end of the day, the red area was approximately 7 inches long by 4 inches wide.  For context, on the day of the vaccine, I had heaviness and some discomfort in my arm (same as I experienced with the flu shot this year), but no redness. All discomfort disappeared in less than 2 days. Was very surprised to have an issue 8 days later.
Flu like symptoms; Weakness; Coughing; Fever; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.      On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) outcome was unknown.        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.   On an unknown date, post vaccination, the patient reported that she experienced flu like symptoms, weakness, fever, and coughing,
This morning he is "feeling horrible."; He took the Covid test today at about 11:30 and he saw that he tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stroke", start date: 2023 (unspecified if ongoing), notes: 12 weeks prior to this report. The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 21Nov2023, outcome "unknown", described as "He took the Covid test today at about 11:30 and he saw that he tested positive"; MALAISE (non-serious) with onset 21Nov2023, outcome "unknown", described as "This morning he is "feeling horrible."". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient with chemotherapy. The patient's medical history included herpes zoster. On 28-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N012614, subcutaneous for prophylaxis. Other suspect therapies included everolimus (AFINITOR), sterile diluent (STERILE DILUENT) and lenvatinib mesylate (LENVIMA). On 28-JUL-2017, the patient experienced medication error. On approximately 31-JUL-2017, the patient experienced influenza like illness, pain in extremity, burning sensation and injection site mass. The outcome of injection site mass, medication error, pain in extremity and burning sensation was unknown. The outcome of influenza like illness was reported as recovered/resolved. The reporter considered medication error to be not related to sterile diluent (STERILE DILUENT) and ZOSTAVAX. Additional information has been requested.
Had shingrix in 2017, has shingles now/Suspected vaccination failure; Shingles; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In February 2023, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had Shingrix vaccine in 2017 and reported that he/she was in a shingles outbreak right now, second week and painful. The patient reported that not sure if Shingrix vaccine was helped at all. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt experienced a palm sized indurated area with erythema over injection site. Warm to touch.
hands swelled up; had a arthritis left over in my middle finger; heart irregularities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "hands swelled up"; ARTHRITIS (non-serious), outcome "unknown", described as "had a arthritis left over in my middle finger"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "heart irregularities". The event "had a arthritis left over in my middle finger" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that his hands swelled up for 3 months as soon as he got the first shot and when it went down, he had a arthritis left over in his middle finger. No prior vaccinations to COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
05/05/2003: 5 large lesions noted-2 on temple, 1 arm, 1 nick, 1 foot. 05/06/2003: 10 more lesions on back, chest, arms, buttocks and genitals. 05/07/2003: 15 more-original lesions and open and draining.  Temperature 100 degrees, and child fussy. 05/09/2003: 2 new pox, old lesions open and draining.  Chicken pox disease in community, but no known exposures.
Mild symptoms for a day and half. Headache, achy. Sinus was bad 13Aug and got tested for COVID, ran a fever on sat, lost taste and smell on Sunday. Coughing and temp gone up 104 degrees on Tuesday and couldn't go down. Went for a monoclonal infusion 17Aug2021. Next day oxygen was 82, fever didn't go away till 23Aug2021. I had tinnitus and loss of hearing. Can't taste or smell yet. I am wearing a hearing aid. Sinus surgery on 30Jul2021.
fever, chills, nausea, headache, bodyache;  about 48 hours post vaccine developed full body rash/itchy.  The rash is not uncommon for me when I have a fever.  I had postive Covid on November 10 - 2.5 weeks of fever, chills, bodyache, zero energy.   It is Monday at 10:00 am and still have symptom/side effect of no energy, bodyache.  Fever appears to have subsided.  Fever was 101 and 101.5
COVID illness; COVID illness; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "T1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: Amoxicillin" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG taken for blood insulin abnormal; LEVOTHYROXINE; INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 18:00, outcome "unknown" and all described as "COVID illness". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical courses: Other medication in 2 weeks: Insulin, Humalog, Levothyroxine. AE treatment: Advil.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202200770433 Same patient, different product and event