chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; 15 yr old patient received an adult dose of VAQTA; This spontaneous report was received from a nurse referring to a 15-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 24-JAN-2020, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) injection 50/1.0 units per milliliter (U/mL) (dose #, schedule and route were not reported) lot # S018772 and expiry date 07-JUL-2020 for prophylaxis (incorrect dose administered). No additional adverse effects reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 11-MAY-2011, the patient was inoculated with ZOSTAVAX at a pharmacy (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Fever; body ache; Low grade Fever; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade Fever), HEADACHE (headache), MYALGIA (body aches), PYREXIA (Fever) and MYALGIA (body ache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19. Concomitant products included CLONAZEPAM for Anxiety, ATENOLOL for Blood pressure measurement.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Low grade Fever), HEADACHE (headache) and MYALGIA (body aches). On 10-May-2021, the patient experienced PYREXIA (Fever) and MYALGIA (body ache). On 08-May-2021, PYREXIA (Low grade Fever), HEADACHE (headache) and MYALGIA (body aches) had resolved. At the time of the report, PYREXIA (Fever) and MYALGIA (body ache) outcome was unknown. Not Provided          Treatment included ibuprofen and Tylenol were noted.
These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.
4 hours after GARDASIL 9 administered, patient developed arm pain and axillary lymphadenopathy on the same side as injection. No fever no fatigue. Resolved completely in 4 days without treatment.
Headache, vomiting,  body aches, my skin felt like it was burning off, eyes light sensitive, joints hurt, my neck hurts
17. y.o. femlae  scheduled for 1st dose phizer. She will be back at unknown date due to grandmother passing away in another country, making acquisition of a second dose questionable. As the other country has been a difficult and highly impacted, I offered the Jannsen one-dose vaccination with the understanding or thought that all 3 vaccine brands were available for those 16 years of age or older. The Jannsen vaccine was administered. The pharmacists I consulted were unaware of the patient age - no their fault.This RN attempted get patient protected, not knowing Pfizer is the only vaccine  for those 16 years and older. Will be 18 years old in May. No known adverse event. Chart review does not reveal any issues yet.
Moderna dose was given first then Fluarix dose was administered, patient immediately experienced a syncopal episode with some shaking associated with it. Patient came to and declined EMS services but remained in the pharmacy waiting area under observation for 20 additional minutes after with no more reported effects.
Body aches and pains and fatigue  - initially - they were mild; Those lasted six days. About a month later, I noticed I was getting more migraines and experiencing more of my symptoms with fibromyalgia. For the migraines and for the fibromyalgia, they increased my Topamax and Gabapentin dosages. That helped with my headaches. And I got on different meds for the fibro -I am taking  Lyrica for the fibromyalgia now and not taking Topamax at all now. Migraines are stabilized now and the fibromyalgia is the same and it's at the point where I just have to deal with it. Pain and sometimes I get neuropathy in bot feet feet. The neuropathy is a bit better with the Lyrica. Fatigue is really bad.  Urgent Care visit somewhere in there.
can't handle antibiotics or seafood/allergic to them; can't handle antibiotics or seafood/allergic to them; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored Program COVAX Support (report's cousin). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced can't handle antibiotics or seafood/allergic to them. The outcome of the events were unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Mom reports 25cent size lump with redness top of right leg approximately 2-3 hours after injection.  Appointment was at 3:30pm.  25 cent size was largest presented to office 08/11/2003 AM with concerns poor walking for 1 week.  That is better but 1cm size nodule remains right anterior thigh.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 19-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
4/23/2021 ? Second Moderna Covid vaccine  5/18 & 5/19 ? Significant vertigo during middle of the night. Woke up multiple times each night in a rapid spin and nausea  5/19 ? Tinnitus in both ears (still present) Sounds like high pitched whistle.
Low grade fever; fatigue; Low grade fever, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, and the sore arm, all from the first shot.; achy body; two small shingles like rashes; Loss of appetite; Headache; sore arm; Muscle Aches; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (at the age of 54-years-old) as single dose for covid-19 immunisation. Medical history included autoimmune issues and covid-19. Patient had no known allergies. Concomitant medications included ibuprofen. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, patient experienced low grade fever, muscle Aches, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, headache, and the sore arm, all from the first shot. Therapeutic measures were not taken due to the events. Since the vaccination, has the patient been tested for COVID-19. The outcome of all the events was recovering.
high fever 102 for 48 hours. muscles and joint ache. head ache  pain and swelling at injection site chills
pt recv one 20 mcg dose for prophylaxis; one hr p/vax exp burning in rt arm and pain and itch at inj site; a\ difficult breathing, faintness, nausea,burning in throat, itch on face and chest, rash; tx w/ pred, Benadryl,Sus-Phrine
"Low grade fever" 24 hours 11/14/03. 20 lesions across trunk, neck, 1 near eye, scalp, cluster area on one thigh (as reported by mother) now crusted over. Neighbor's 2 siblings with + varicella, several cases at local elementary school.
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On 19-JUN-2012 the patient was vaccinated subcutaneously in the left upper arm with a single dose of live ZOSTAVAX (lot # 1716AA, exp. date:02-FEB-2013). On an unknown date of 2012, initially patient developed redness and swelling at the injection site which resolved without requiring medical treatment. The patient subsequently, on an unspecified date of 2012, developed "pain on the side of the left arm extending about 5 inches". The pain had been "persistent for the last few months". No lab diagnostic studies performed. No treatment was given. The patient came to the pharmacy to seek medical attention. The outcome of the pain on the side of the left arm was not recovered. The relatedness between the events and live ZOSTAVAX was unknown. Additional information is not expected.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via agency.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose Number: 2, Batch/Lot No: 076C2117, Manufacturer: Moderna), administration date: 23Sep2021, when the patient was 68-year-old, for Covid-19 Immunization; moderna (Dose Number: 1, Batch/Lot No: 939906, Manufacturer: Moderna), administration date: 26Aug2021, when the patient was 68-year-old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19".  Clinical information: If vaccine received: Yes. Known allergies and other medical history were unknown. Other medication in 2 weeks were unknown.
She has been experiencing elevated blood pressures and mild, non-focal headaches. She was admitted to the hospital on 8/6 and received the first dose on 8/9. Since 8/6, she has had intermittent high blood pressure readings trending upwards with a peak of 171/80 on 8/13. She was started on amlodipine 5mg daily on 8/14. Prior to starting dialysis in 2015, she had a history of hypertension and used antihypertensives. After starting dialysis, she did not need meds to lower her blood pressure. We were able to follow-up on home blood pressure recordings (which she checked once a day) which were intermittently elevated with systolics  no higher than 140s. She did have daily headaches at home for some time, prior to the vaccination, which were helped by Tylenol. We started to note blood pressures in the 150s starting 8/12. (Blood pressure in the hospital is checked several times a day, as opposed to once a day as she was doing at home). She was still having her daily headaches. Her blood pressure peaked on 8/13 to 171/80 when amlodipine was started. Since starting amlodipine, she feels that her headaches have resolved and her blood pressures have improved.
Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
developed SVT during observation period ( heart rate 150s to 180s ) (history of recurrence SVT stress ), taken to ED  immediately
Patient complained of numbness in top of left hand. After 5 minutes, numbness remained despite flexing fingers, movement. Vitals taken with assessment. After another 5 minutes, numbness gone. Kept under observation for 30 minutes and then released.  Note from MD: 39 year old male who complained of top of hand numbness after injection lasting 10 minutes or so. No other complaints, no neuro issues. History of TIA with left-sided weakness. Exam: no neuro deficit. Plan: follow-up with primary care provider.
approx 2hr p/vax rt arm was very painful & swollen;hard knot in area of inj;a small bruise appeared the same noc by morning a 4x6 bruise was on outside of arms;bruise cont to enlarge from upper arm to elbow & around the circumference of elb
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: blood pressure, and back, and other 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for back, and lisinopril for blood pressure.  On 31-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
PATIENT RECEIVED 3 DOSES OF SHINGRIX RATHER THEN THE RECOMMENDED 2 DOSES.  SHE RECEIVED 1ST DOSE ON 10/31/2021, 2ND DOSE ON 04/14/2022, AND A THIRD DOSE ON 05/09/2023.  PATIENT DID NOT REPORT ANY ADVERSE SIDE EFFECTS, JUST WAS QUESTIONING IF SHE RECEIVED 3.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.  Vaccine expiration date was 24 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received and it contains no significant information.
Anaphylactic shock; feeling some stuff in my throat; A spontaneous report was received from a 56-year-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic shock and feeling some stuff in my throat.   The patient's medical history included having general allergies. Concomitant product use was not provided by the reporter.    On 28 Dec 2020, immediately prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, while the vaccination needle was being pulled out of the patient's arm, the patient experienced anaphylactic shock. Two epinephrine injections were used within ten minutes of the reaction. The patient continued to take steroids due to her still feeling some stuff in her throat at the time of reporting. Treatment for the events included two epinephrine injections and steroids.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, anaphylactic shock, was unknown. The event, feeling some stuff in my throat, was considered not resolved.; Reporter's Comments: This case concerns a 56-year-old female patient with medical history of unspecified allergies requiring Epi-pen,  who received their first of two planned doses of mRNA-1273 (Lot 025J20A), and who experienced a serious unlisted event of Anaphylactic shock and a non-serious unlisted event of Oropharyngeal discomfort immediately following vaccination.  Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The patient's history of general allergies requiring Epi-pen remain as confounders.
BODY ACHES; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 39 year old old of unspecified 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: 1816022 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced fatigue. On 29-JUL-2021, the subject experienced fever. On 29-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, fever, headache and body aches was not reported. This report was non-serious.
0955 given flu injection L arm (upper mid delt.) and reports after 5 min started itching and slow increased to both arms and neck after 10 mins. Pt comoplained to staff of itchying and red swelling over and neck. 50mg Beandryl given 101.5. Itching stopped 1025.
sent in from urgent care for pneumonia and covid 19. Patient states had symptoms for the past few days very short of breath and heart racing; xray shows pneumonia
Dizzy, light headed, flushed and warm, some cough, a little bit of a sore throat. denies unusual rxn from Smallpox vaccine, was unaware of having a fever. Dx: most likely a viral type problem. Temp 102.4