chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXTENSIVE DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronary artery disease. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extensive deep vein thrombosis after the vaccine was released to the public. She began feeling symptoms seven days after getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extensive deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210514131- COVID-19 VACCINE AD26.COV2.S -Extensive Deep Vein Thrombosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1802USA004732, US-009507513-1802USA004733, US-009507513-1802USA004734, US-009507513-1802USA004735, US-009507513-1802USA004736, US-009507513-1802USA004737, US-009507513-1802USA004738, US-009507513-1802USA004739, US-009507513-1802USA004740, US-009507513-1802USA004741, US-009507513-1802USA004742, US-009507513-1802USA004743, US-009507513-1802USA004744, US-009507513-1802USA004745, US-009507513-1802USA004746, US-009507513-1802USA004747, US-009507513-1802USA004748, US-009507513-1802USA004749, US-009507513-1802USA004750, US-009507513-1802USA004751, US-009507513-1802USA004752, US-009507513-1802USA004753, US-009507513-1802USA004754, US-009507513-1802USA004755, US-009507513-1802USA004756, US-009507513-1802USA004757.
within 15 min felt different when swallowing but heart rate and breathing was normal.  patient is sensitive to vaccines and many medications, typically breaks out in a rash. current symptoms did not worsen in the 30 minutes she was here. did mention being anxious about the vaccine. felt comfortable leaving and was advised to seek emergency care if symptoms worsen
22Jul98 Pt recv vax.  Pt. exp. lethargic, fussy, irritable, dec appetite. Sx gradually increased was admitted to hosp. for eval.  Did not respond to mom; pt remained irritable and fussy.
pt mom reported pt devel hives the day following immun;pt devel facial & pedal edema 1 1/2 days post vax;tx w/pred, cimetidine & cont use of med;
Sevier Low Back Pain; Sevier low back pain; Slite Headacke; This is a spontaneous report received from a contactable consumer. A 72-year-old consumer(patient) reported in response to Non-HCP letter sent to consumer which included that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:15 (Batch/Lot Number: EN6201; Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included knee operation from Jun2020 and ongoing Osteoarthritis Knee surgery Pertinent details: 06-2020 , ongoing osteoarthritis Back, Hips and Neck In stop date : she mention osteoarthritis , cerebrovascular accident from Jun2017 to an unknown date Family medical history: Mother- Stroke & COPD Father- Lung Cancer & COPD; Mezolthezmalona Grandmother- Stroke , arthralgia, hormone replacement therapy ocular discomfort , hypotonia Concomitant medications included paracetamol (TYLENOL) taken for arthritis, arthralgia oestrogens conjugated (PREMARIN) taken for hormone replacement therapy orphenadrine taken for hypotonia . The patient experienced severe low back pain on 08Feb2021 slite headache on 06Feb2021 18:00 severe low back pain on 01Mar2021The patient underwent lab tests and procedures which included covid-19: negative   on Mar2020 Comments:  Respiratory Infection, covid-19: negative   on Dec2020 Comments:  Sinus Infection. and outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Severe exhaustion for several days including vaccination date, bruising and prolonged irritation, redness, swelling and itching  over a week after vaccination at injection site.
client already anxious prior to vaccine per nurse, post vaccine client complained felt "faintlike" Per Nurse client had "dazed like look" on her face. EMT and MD evaluated client,  client responsive reports history of diabetes, did not take insuling this morning and did not eat this am. BP 169/100 HR 94 Blood sugar 321. MD asks client to take deep breaths, client start rubbing her chest complainingof chest pressure. MD recommends client be trnsported to hospital. EMT called FD for tansport in the meantime will do 12 lead EKG. ParaNSR, client declined transport to ER. Daughter to pick up and take to hospital. Sister at clients side, client left without incident at approx 1135
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received MENVEO. Concomitant products included Multivitamin. On 22nd September 2015, the patient received MENVEO .5 ml. On 22nd September 2015, 30 min after receiving MENVEO, the patient experienced vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain. On an unknown date, the outcome of the vomiting, dizziness, headache, back pain and abdominal pain were recovered/resolved and the outcome of the injection site swelling, injection site pain and injection site warmth were not recovered/not resolved. The reporter considered the vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain to be related to MENVEO. Additional details were received as follows: On 22nd September 2015, 30 to 40 minutes of vaccination, the patient experienced vomiting, dizziness, headache, injection site swelling and soreness. Injection site was also described as warm or hot to touch. The injection site issues were continue at the time reporting. On 22nd September 2015, later in the evening (several hours after vaccination), the patient experienced extreme abdominal and back pain. Due to the events, the patient was taken to the emergency room. The patient underwent a series of tests specific to appendicitis. The appendicitis was ruled out. Vaccine Service Center transferred the caller. The reporter was seeking reimbursement from GlaxoSmithKline, specific to medical bills associated with the event. The reporter has physician notes or records that she would like to submit to GlaxoSmithKline. The reimbursement process was reviewed with reporter, stating that reimbursement is typically only considered for product cost (not medical bills).
The first vaccination dose when we went to the car we sat in the car for 15-30min. After about an hour I started to have Paraoxysmaldyskinesia and seizures (they are secondary condition to the MS). And I began to have this in the car. I started to have paralyze in both legs but my left leg began to hurt. And I began to have terrible diarrhea and I have Chron's disease and I have a Ileospomy bag (and I've had this since March of 2017). A week later after vaccination I had an infusion of Entyvio (biologic) which is regularly scheduled and happened to be a week after the shot. It helped the diarrhea. I contacted my GI doctor to ask if they could move up my infusion to so it could be after my next dose. They said all their patients are seeing diarrhea after vaccination and no they couldn't move it up.  I continued to have pain in my legs, fatigue even after going up stairs, difficulty walking. In 2014 I had Sciatic in that leg and a blood clot so I thought it was due to that and never assumed it was  a blood clot. And the pain was getting worse each day but I assumed it was all related to the Chron's and not a blood clot.
Localized erythema at site of injection at LA and swelling. Baby moving arm and using it well. RX: Cold compresses and F/U.
pt recv vax 9JAN98 & 19JAN98 pt presented to ER w/achiness & a sl fever;pt thought had the flu;tx w/biaxin;21JAN98 pt devel rash described as little red-like pimples on face, hair line,back & trunk;also c/o joint tenderness;
Already got vaccinated. but tested positive for Covid today; Already got vaccinated. but tested positive for Covid today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2023, outcome "unknown" and all described as "Already got vaccinated. but tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) positive, notes: tested positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever, muscle aches, headache, malaise, queasiness, dizziness, confusion, vomiting later in morning
Began with pain around injection site for first twelve hours, progressed to more severe pain throughout injection site arm and then to other arm and legs. Also experienced low grade fever for which she took tylenol. Took about 3-4 days total to resolve.
Within 24h of vaccination, pt develop fever to max temp of 39.2C as well as significant headache associated with photophobia. Fevers and headache persisting to following day. ~48h after vaccine, pt noted large area of erythema with associated tenderness along lateral L upper arm around injection site.
This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin). At the time of the report, MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-107844 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-107844:For Reporter.
patient received a 4th dose due to being immune compromised.  He received a full dose instead of a booster dose.
body pain; Headache; Nausea; Fever; This is a spontaneous report received from a contactable consumer (patient). A 21-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Patient stated that after getting the second dose of the Pfizer COVID 19 vaccine she experienced body pain, headache, nausea and fever. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt left tent 13 to observation lane.  Pt. was complaining of tingling hands.  Paramedics monitored until symptoms subsided.  Paramedics released pt. to leave.
HEADACHE; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt nauseous. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt nauseous on 11-APR-2021. This report was non-serious.
per mom & noted from MD pt had a hypotonic episode;pt DTP temp 103.4;
Patient c/o still having significant pain, swelling, and redness in a 2 inch diameter at injection site two days after receiving the vaccine.
I went to the bathroom, wiped and had tremendous amounts of blood on the toilet paper. I also experienced abdominal cramps on the left and right sides. This bleeding went on heavily through the time I got in with my OBGYN on Tue., Sept. 7 for assessment. I treated the whole time with tampons and pads. I was soaking through a couple of tampons an hour. Very scary for a 57 year old woman who has been in menopause for 10+ years.
Localized VARICELLA reaction - redness @ the site started 1-28-09 in evening.
The grandmother called the facility and stated her grandbaby had a rash on her face the next day and gave Benadryl and the rash went away.
A report has been received from a Pharmacist concerning an adult, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that a patient over 49 YOA received FLUMIST QUADRIVALENT. The outcome of the event of patient over 49 years of age received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 11-Nov-2014: reporters details updated. Narrative updated.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in 1997 or 1998, the patient was vaccinated with three doses of Hepatitis B vaccine (manufacturer unknown) (routes of administration, doses, frequency, lot numbers and expiration dates were not reported). On 18-JAN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (route of administration, dose, frequency, lot number and expiration date were not reported) (initially reported as an unspecified vaccine administered in error). The reporter additionally stated that the event was reported since the patient received four doses of Hepatitis B vaccine (both Hepatitis B vaccine (manufacturer unknown) and RECOMBIVAX HB counted together), which was outside of RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information is not expected as no consent for correspondence contact was reported.
Unexpected therapeutic effect; energy boost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2022 10:30 (Lot number: FL3209) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "Unexpected therapeutic effect"; ENERGY INCREASED (non-serious), outcome "recovered", described as "energy boost". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have family medical history relevant to events. It was stated that after the vaccination approximately 25 to 30 minutes later the patient felt a tremendous energy boost and when arrived home maybe 45 minutes after the shot was administered the patient  went and shoveled snow off our two driveways and a long sidewalk and didn't break a sweat nor was tired at all. The patient wish to could get second shot earlier. It was amazing.  thought you would like to hear that. The patient did not receive prior vaccinations (within 4 weeks). The patient did not have arm pain, no muscle pain, in injection site experienced boost of energy lasted 24 hours (up to 36 hours), came home shoveled after shot, entire drive way/side walk, no fatigue, no heart palpitation and no ill affect from the shot.  No follow-up attempts are possible. No further information is expected.
Patient developed a quarter sized lump at injection site the days after receiving the injection. This was raised and red according to patient's report. It persisted for 4 days and resolved on its own. Patient also developed muscle aches, fatigue, and slight headache. These persisted for 1.5 days.
It has cause my warts to recede and skin seems smother. Great side affect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:00 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "diabetic" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "kidney stones" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "gallstones" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc; "fatty liver" (unspecified if ongoing), notes: Event verbatim: heart, diabetic kidney stones gall stones fatty liver, etc. The patient took concomitant medications. Vaccination history included: Bnt162b2 (administration time:12:00 AM,, dose number:1,, vaccine location: Right arm), administration date: 02Feb2021, when the patient was 70 years old, for COVID-19 immunisation.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 24Sep2021, outcome "unknown", described as "It has cause my warts to recede and skin seems smother. Great side affect". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: The patient reported side effect, he had noticed since he had two shots It has cause his warts to recede and skin seems smother. Great side effect. May have other uses. Great work After all they are virus related. The vaccine was administered at Hospital. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. was not result in emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Pt called and stated that her arm was sore that morning but after her nap this afternoon arm was swollen, itchy, and red.  Told pt that she could take a Benadryl if she thinks it is an allergy.  Pt called the doctor and went to see doctor the next day (1/21/15). Dr prescribed cyproheptadine 4mg.  I twice daily for 3 days and then as needed.
Information has been received from a licensed practical nurse concerning a 65 year old male who at 9:11 AM, on 08-NOV-2006, was vaccinated intramuscularly in the left deltoid with a first dose of Pneumovax 23 (Lot# 654981/0674F).  There was no illness at the time of vaccination.  On 09-NOV-2006 the patient developed redness and swelling with extension of redness into left upper arm, down to wrist, axilla area.  It was also reported that "the injection site was within normal limits although beyond it was red".  The patient was treated with antihistamines and antibiotics.  The patient was reported to be doing well on 13-NOV-2006 and would finish antibiotics on 15-NOV-2006.  The patient was considered recovered on 15-NOV-2006.  Additional information is not expected.
Patient received 0.3 of Pfizer pediatric undiluted instead of the Pfizer Bivalent adult vaccine
Local redness, warmth, swelling, itching 20 minutes post administration Benadryl PO.
Can't bend knee; Can't go up/down steps; Patient is not able to work; Chills; Severe knee joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 30LZ30A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain). At the time of the report, MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain) outcome was unknown.            Concomitant medications were not provided Treatment information include Advil, ice. Voltaren tablet for pain . Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-017697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The Additional information document received on 10-MAY-2021.Repoters email id was added. First dose information was added. Treatment  information is added.
Extreme tiredness for 24-48 hours after first vaccine. Slight pain in arm where site of vaccine was. Experienced extra thirst. Had vivid dreams/ nightmares for few days following vaccine.
On 5MAR91 pt had high temp; Since mom couldn't control it w/antipyretics, taken to Hosp-hospitalized @ that time w/SOB;