chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My Vaccination record is incorrect and does not list the Moderna lot number. It incorrectly list pfizer.  Prior history of a free neck injuries such as car accidents last one in 2020, 2019, 2013, 2010 No pain for almost a year, previous pain was right shoulder after 2019 accident and 2020 accident The report to vsafe was before I had the MRI done and I thought it was shoulder pain. I am not sure if the inflammatory/immune response would flare up the old injuries.  I never communicated the vaccine date to my doctor. She is unaware  2/2/22 shot in left arm-felt fine that day.  2/8/22 woke up in severe pain. Right shoulder 9/10 pain. Had xray on 2/9/22 -1. Mild osteoarthritis right acromioclavicular joint. 2. Mild calcific tendinitis. Referred to another doctor xray on 2/10/22 Degenerative changes are noted with intervertebral disc space narrowing and facet arthropathy as described above with apparent moderate bony foraminal narrowing on the right at C3-4.  MRI on 2/16: CLINICAL HISTORY: 52 years Female, M54.12: Radiculopathy, cervical region. Sudden onset right shoulder pain with numbness in right.  COMPARISON: X-rays of the cervical spine dated 2/10/2022.  TECHNIQUE: Multiplanar imaging was performed with T1 and T2 weighted sequences were obtained.  FINDINGS:  Alignment: Normal.  Discs: Mild disc desiccation at C2-3 through C4-5. Mild disc height loss at C5-6.  Osseous structures/marrow: Osseous marrow signal is normal. No evidence of acute fracture or focal suspicious osseous lesion.  Central canal: The central canal is relatively narrowed secondary to shortened pedicles and measures approximately 12 mm in AP dimension.  Cervical cord: Normal in size and signal.  Craniocervical Junction: Normal.  Paraspinous soft tissues: No significant paraspinous soft tissue abnormalities are demonstrated.  C2-C3 : Mild facet arthropathy, right greater than left. No significant central canal or neuroforaminal stenosis.  C3-C4: Mild to moderate right and mild left facet arthropathy. Mild right-sided uncovertebral spurring. Minimal central disc protrusion. Moderate right foraminal stenosis. No significant central canal or left foraminal stenosis.  C4-C5: 2 mm central protrusion. Mild bilateral facet arthropathy with mild uncovertebral spurring. No significant central canal stenosis. Mild nonimpinging bilateral foraminal encroachment.  C5-C6: 4-5 mm right paracentral disc extrusion extending into the proximal right intervertebral foramen. Small portion of extruded disc extends in the right lateral recess. Severe proximal right foraminal stenosis with moderate to severe right lateral recess stenosis and mild right central canal stenosis. The left foramen is patent.  C6-C7: 2 mm central protrusion. No significant central canal or neuroforaminal stenosis.  C7-T1: No significant disc bulge or facet arthropathy. No significant central canal or neuroforaminal stenosis.
About 15min after injection given pt stated, she was hot. Pt took BENADRYL supplied by  employer, five min after BENADRYL she c/o trouble breathing. She grabbed employee stated I can't breath - Epi was given (L) arm and called 911. Gave Epi. 3 above site and 2 (R) arm, after injection started convulsing. Lowered to floor w/o injury.  5min after convulsing she regained consciousness, parameds took to hospital awake at time of transport.
Information has been received from a registered nurse concerning a female with no pertinent medical history who on 15-MAY-2007 was a 0.1 ml dose of vaccinated intradermally with Pneumovax 23 (lot # 655766/0038U) instead of tuberculin purified protein derivative. On 15-MAY-2007, the patient experienced redness, hardness and swelling at the injection site. On 15-MAY-2007 in the evening, the patient went to the emergency room for the local reaction. There were no laboratory or diagnostic tests performed. 16-MAY-2007, the patient followed up with the physician. Additional information has been requested.
Pt reported feeling funny, anxious with chest tightness one hour post vax. Also complained of bilateral hand numbness. This feeling occurred intermittently every few minutes. Resolved after a few hours with no treatment.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient received 2 on schedule doses of Shingrix 1st dose 18th September 2018, and 2nd dose received on 19th January 2019.  The patient reported that they believed they had the Shingles at the time of administration of the second dose. There was no clear timeline between diagnosis and administration of the 2nd dose as the patient did not report the event until 9 months later. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up.
Patient felt nervous/afraid Denied SOB, pain, dizziness patient had anxiety attack after vaccination since childhood offered cold water and large breathing slowly
Chronic palpitations, ear ringing, vertigo. From second dose on 2/15/21
The wheals are all over the body; Broke out with rashes all over his body primarily on buttocks, groin area and back.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The wheals are all over the body) and RASH (Broke out with rashes all over his body primarily on buttocks, groin area and back.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced URTICARIA (The wheals are all over the body) and RASH (Broke out with rashes all over his body primarily on buttocks, groin area and back.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 2 tablets. At the time of the report, URTICARIA (The wheals are all over the body) and RASH (Broke out with rashes all over his body primarily on buttocks, groin area and back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication listed.   Treatment:Topical ointment
felt fine minus some soreness at injection site until 2:30am the following day. woke up to take my dog out to potty and after getting outside became light headed. made my way back into the house and then fainted and was too weak to get back up. had to have boyfriend come help walk me back to bed. slight weakness, minor headache, and fever since then.
No adverse event; a patient received the first dose of GARDASIL 9 in 2020 and then received the second dose 5 months ago (in 2022); This spontaneous report was received from a pharmacist, refereing to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified date in 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on an unspecified dae in 2022, the patient was vaccinated wth the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strengths, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported), both as prophylaxis (inappropriate schedule of product administration).
Within 2-3 hours, arm became painful and began to swell; spent evening with ice to sight and took acetaminophen; difficulty sleeping as arm hurting so much; by morning arm swollen to below elbow, unable to arm much at all due to pain; feeling ill....nauseated, chilling, light headed; returned to bed....unable to dress or eat much that day. By following day, arm swollen clear to wrist and still very painful; Taking BENADRYL to help, but didn't seem to do much. I was able to bathe and dress but still felt ill. Some improvement to swelling in upper arm but whole arm red, warm and still very swollen. Over the course of a week, symptoms abated and swelling slowly receded. I have not been so ill in a very very long time.
Abrupt onset of lichen planopilaris (frontal fibrosing variant); This is a spontaneous report received from a contactable reporter(s) (Physician). A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2020 19:15 (Lot number: EJ1685) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroid disease" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN XL. The following information was reported: LICHEN PLANOPILARIS (non-serious) with onset 06Jan2021, outcome "not recovered", described as "Abrupt onset of lichen planopilaris (frontal fibrosing variant)". The event "abrupt onset of lichen planopilaris (frontal fibrosing variant)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lichen planopilaris.  Additional information: No other vaccine received in four weeks. The patient received treatment with intralesional triamcinolone, hydroxychloroquine, dutasteride, mycophenolate mofetil, clobetasol, tac. No covid prior vaccination and tested for covid post vaccination. No Known allergies.   Follow-up attempts are completed. No further information is expected.
?COVID arm? (itching and red, circular rash about 1.5 inches at injection site, left arm), these symptoms presented exactly one week after receiving first vaccine dose.
HE SAID HIS CHEST FELT TIGHT.  HE SAT FOR 5 MORE MINUTES AND WE WATCHED  HIM. HIS WIFE WAS WITH HIM. HE DECIDED HE FELT BETTER AND WANTED TO LEAVE.
Pounding chest turned red, tapid heart beat & breathing, muscle pain, mild headache, fatigue, diarrhea, low grade fever
I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product 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.
This spontaneous report was received from a nurse and refers to a 11-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date, site and route of administration were not reported) for prophylaxis. On the same date, the patient was vaccinated concomitantly with MENACTRA. On an unknown date, the patient might had been experienced migraines, nausea, hoarseness and trouble running in Gym class before and after vaccination. It was also reported as ''the nurse believed the patient had these symptoms before the GARDASIL 9, however the patient's parents believed the symptoms started after the vaccine''. The outcome of the events was unknown. The causality assessments were not provided.
Implant site swelling to face; This is a spontaneous report based on the information received by Pfizer from a contactable other healthcare professional.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received hyaluronic acid (RESTYLANE) for an unspecified indication on an unspecified date.  On an unspecified date the patient experienced Implant site swelling to face post Restylane Lyft injection. Patient received Pfizer COVID 19 Vaccine 1 week prior to injection. Outcome of the event Implant site swelling to face is unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
patient returned to pharmacy in about an hour to an hour and a half with rash/hives she stated she called her Provider and they instructed her to take a benadryl  and the patient has an appointment in the morining patient returned about 30 to 45 minutes later and we agreed she should go to a minor emergency center for the rash
Patient said she had every symptom of the flu within 2 hours of receiving FLUZONE HD and PREVNAR 13.
No other information available; Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1742457, expiration date reported as 16-FEB-2022, but upon internal validation was determined as 06-JAN-2022 for prophylaxis. No other adverse event was reported.  The vaccine underwent a temperature excursion of 1.3 degrees Celsius (°C) for 19 minutes, with no previous temperature excursions. The call was due to digital data logger.
hard heated small pancake sized red mark around the vaccine with minor itching and no swelling. stayed flat and resolved in a couple of days
8/18/99 child c/o sore lt arm;no visible sx noticed by mom;mom gave motrin & soreness soreness subsided;8/19/99 mom states child lt arm @ inj site is swollen to size of softball & child c/o itching;instructed to apply cool compress, DPH;
was receiving a dose of FLUZONE QIV PFS and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a Other Health Care Professional.  This case involves an unknown age and unknown gender patient who was receiving a dose of fluzone qiv pfs and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event (Influenza quadrival A-B vaccine) [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2022 the patient was receiving a dose of influenza quadrival A-B vaccine (form, strength, dose, frequency, batch number and expiry date: unknown) via unknown route in unknown administration site for Immunization and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm with no reported adverse event" (accidental exposure to product) (latency : same day) .  It was reported Caller reporting that an employee was receiving a dose of FLUZONE QIV PFS and the staff member administering reporting most of the dose leaked out and dripped down the employees arm (patient's arm). Caller reporting that they are assuming that the needle was not screwed on all the way. Caller with question on whether dose need repeating. Caller did not have any patient or vaccine details, therefore smart script not completed.  Action taken was not applicable  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
On 6 Jan 14, patient noticed that the injection site was red. On 7 Jan 14, he noticed that his arm stating becoming hot to the touch. On 8 Jan 14, he noticed that the redness had spread to his elbow. Patient went to the emergency room on the night of 8 Jan 14 and was prescribed antibiotics.
patient reported headache then passed out; 1 dose of epipen given; patient left store with paramedics
Excessive Hair Loss; fever; body aches; headache; dizziness; fatigue; pain in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: FJ8762) at the age of 38 years, on 13Jan2021 as dose 2, single (Lot number: EK9231) and on 15Dec2021 as dose 3 (booster), single (Lot number: EK9231) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "Excessive Hair Loss"; PAIN (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "body aches"; DIZZINESS (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; FATIGUE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "pain in arm". The events "excessive hair loss", "fever", "body aches", "headache", "dizziness", "fatigue" and "pain in arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, pyrexia, pain, headache, dizziness, fatigue, pain in extremity.  Additional information: Adverse event Excessive Hair Loss over the course of 6 months-1 year, fever/body aches/headache/dizziness/fatigue/pain in arm starting day after each injection and lasting about 48hrs. Adverse event start date 24Dec2020. Ae resulted in [Doctor or other healthcare professional office/clinic visit], patient recovered with lasting effects with no treatment, no covid prior vaccination, patient was covid tested post vaccination, there were no known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.
Soreness in upper right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in upper right arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL for Hypertension, NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in upper right arm). At the time of the report, PAIN IN EXTREMITY (Soreness in upper right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    Reporter did not allow further contact
Per pt she was so tired after receiving the vaccine and  and was having the tightness on the chest that she used her oxygen and took a rest for 24 hours after she feels better.
BODY ACHES; CHILLS; FEVER; A LOT OF FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. 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. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, fever, and a lot of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and a lot of fatigue was not reported. This report was non-serious.
Tinnitus -- both ears; a hissing sound that is constant. It doesn't stop and it doesn't stop-and-go. Never had this previously.