chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in Feb2021 as dose 2, single (Lot number: EL9265), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fib" (unspecified if ongoing), notes: Atrial Fib. No known allergies. Concomitant medication(s) included: METOPROLOL, start date: Jan2018, stop date: Jul2022; ELIQUIS, start date: Jan2018, stop date: Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 Treatment with Paxlovid from Jul2022 to FY4422. Patient had unusual taste. Diarrhea started on day two. Would not stop. Doctor discontinued Paxlovid on day 4. Leg cramps, continued through day 6. Diarrhea continued through day 6. Patient received treatment: OTC Imodium for Diarrhea, Pedialyte for cramps.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HPI 25 yo f with hx of anxiety and cp here with co cp.  Pt notes mid upper cp.  She has been exposed to coworker with covid.  Has been having coughing.  No loc, sob, cyanosis or fever.  Review of Systems Constitutional:  No fevers or chills.  Eyes:  No visual changes or discharge. ENMT:  No ear or nasal discharge. No neck pain or stiffness. Cardiac:  See hpi.  Respiratory:  No cough SOB or respiratory distress.  GI:  No nausea, vomiting, diarrhea or abdominal pain. GU:  No dysuria, frequency or burning. MS:  No edema or pain. No back pain. Neuro:  No headache or weakness.  No LOC. Skin:  No skin rash.
Small seizures. Arms straightened, flexed, fists clenched. Chin to chest, and jaw ticked back and forth.
large induration; fever; Chills; vomiting; This is a spontaneous report from a contactable consumer. A 3-decade-old (precise age unknown, early-to-mid 20s) female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and  concomitant medications were not reported. It was reported that post dose 1 of "COMIRNATY COVID-19 mRNA-based vaccine" on 28Dec2020, the patient experienced large induration, fever, chills and vomiting. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a office manager concerning a 30 year old female consumer with no pertinent medical history or drug reactions/allergies who on 29-JUN-2012 was vaccinated with the first dose of VARIVAX (Merck), 0.5 mL, SQ left arm (lot # 0415AE, expiration date unknown). No other co-suspects were reported. No concomitant medications were reported. On 08-JUL-2012, the patient developed redness, itching and stiffness at the injection site. No laboratory tests were performed. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. The patient sought medical attention called the office. The relatedness for stiffness, itching and redness at the injection site was unknown for VARIVAX (Merck). Additional information has been requested.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st July 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported sore arm about 2 to 3 hours after receiving Shingrix. The reporter did not consent to follow up. The batch number was not avaialble.
Patient described redness and swelling at first.  By the time she reported to me, swelling had decreased.  Skin was warm to the touch and very red, like a bad sunburn.  Mild itching.  No streaking.  Redness was over lower part of upper arm.
This spontaneous report as received from a consumer refers to a 69 year old female patient (caller's sister). In approximately 2012 (reported as two years ago), the patient was vaccinated with ZOSTAVAX one dose (dose and frequency unknown). Lot and dosage information was not provided. Concomitant medication was not reported. In 2013, reported as one year later, the patient learned that she had cancer (medically significant) and lymphoma (medically significant). On an unknown date in February 2014 (reported as 2 months ago) the patient experienced shingles in her vaginal area. The caller was not aware of many of the details of the specific situation her sister was experiencing. The outcome of the events was unknown. Unknown treatment was given for the events. Reporter's causality assessment was not provided. Upon internal review, the events cancer and lymphoma were determined to be medically significant. Additional information has been requested.
Body aches, chills, nausea, headache and tired from 12p 6/11/2020 - 9a 6/12/2020. Diarrhea 6p - 12a 6/12/2020. Took tylenol and mobic on 6/11/2020
Patient got a rash on right arm about six inches below the site of injection. They said they are doing fine.
1st dose at 12/23/20 -> myalgia and loss of appetite, both persisting until 01/19/21. 2nd dose at 01/21/21 -> fever, chill, nausea, vomiting, loss of appetite, generalized weakness, fatigue Admitted to hospital on 01/31/21. Initial exam show normal neurologic signs. Several hours after initial exam, patient developed 0 to 1/5 strength in all 4 extremities with absent ankle reflexes bilaterally.
Within two days of getting the shot my ears were bothering me enough almost to the point I was going to call in sick. I thought I had an ear infection. It was an extreme fullness and felt horrible and lasted for a week or two until I felt worse and eventually got better.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a six-years old patient who received an expired 0.5 ml dose of vaccine ADACEL (lot C5065AA, expiration date 08-Oct-2018) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. No Adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient arrived to clinic with grandmother (guardian) for the flu vaccine. Patient was administered VFC flulaval guadrivalent due to eligibility that has expired. Doctor provider on duty made aware of the situation and advised that no harm was done; however, patient would need to return in a week to get vaccinated with this year's flu vaccine for better protection from this year's virus. Grandmother notified and was made aware of the med error and recommendation by Doctor.  Grandmother verbalized understanding and made an appointment to bring the patient back for vaccination. Grandmother decline seeing a provider when offered for further medical advise and education when writer offered the option.  Doctor patient's pediatrician notified and made aware. LVN.
A non-serious spontaneous report of woman in her fifties received a dose of H1N1 LAIV was received from a physician concerning an adult female. Neither relevant medical history nor concomitant medications were reported. On 02-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt returned to clinic 1 month, post vax, and states that her right arm became very red and swollen at the site of injection and now has difficulty with moving arm.
Mild headache after vaccination progressed to intractable migraine on day 5. Called ambulance for transport to ER where IV migraine meds were given.  Headache did not abate and 4 days later again went to ER for IV migraine medications and MRI to assure there was no bleeding in brain. MRI clear. Follow up appointment with healthcare provider after second ER visit.  Migraine lasted 3 weeks and required prescription barbiturates to manage.  Patient unable to work for 3 weeks.
Initial report received from an health care professional on 29 Jul: This patient was vaccinated with only the 0.5 ml of the MenCYW-135 component of MENVEO (batch numbers: (box lot: 100003 and liquid vial lot: 091001) without the lyophilized Men A conjugate compound. No adverse events had occurred following this administration.
After the initial Hep B injection on 10-7-18 I became extremely anxious, my sleep was disrupted, was unable to concentrate, and cried easily. All symptoms were abnormal as I am typically a very upbeat, well-adjusted person. Also noticed that I was feeling stiff in my joints over my entire body but especially my neck. When the second in the series of Hep B injections was given on 11-04-08, all the above symptoms increased exponentially. Had I not known it was in response to the immunization, my reaction was so sever I would have sought psychiatric help for my symptoms. These symptoms began within the day of each injection and seem to increase over several weeks, plateauing aproximately 3 to 4 weeks out. To this date they have slightly decreased maybe 10%. On 11-4-08 I also recieved a Td immunization. About 5 or so minutes after these two injections were recieved, I started to feel odd, like I would pass out. Thus, I sat in the waiting room for about 20 minutes hoping it would pass. No one asked about my condition and I felt too poorly to seek help. Eventually I went to my car and reclined for at least another 30 minutes as I was afraid to drive in my condition. Initially I self treated, eliminating any stressors possible, took magnesium at bedtime to enhance sleep, and vitamins and bioflavinoids to bolster my immune system and deal with inflammation. I was not ill at the time of the immunizations nor was I taking any drugs. Eventually I spoke with a PA who advised I discontinue receiving the full series of Hep B given my personal response.
Menstrual cycle is typically VERY regular. However, after getting vaccine booster, I am, as of today, 9 days late. There is NO chance I am pregnant.
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA002834: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
Patient noted that after first shot of vaccine her menstrual cycle ceased. This remained persistent until she saw gynecology for progesterone therapy in which it restarted in April 2021. Prior to her vaccination her menstrual cycles were normal and regular.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Patient developed pruritic rash 10 min after vaccine administration. She was given antihistamine with improvement in her rash, and symptoms. She was discharged home from the vaccination site in improved condition.
Pt. experienced heart palpitations. Starting evening of receiving vaccine. He felt bad for several days and consulted physician. MD unsure if related to vaccine as pt. has a history of arrhythmias for that condition.
Sensitive skin started developing on 3/6/21; diagnosed with shingles on 3/8/21
Severe Headache within 15 minutes and within a half an hour - stiff neck and weird sensation when swallowing.
3 days of cough, shortness of breath.  Described as a wheezing cough, very chilled and achy
Fever, NauseaVomiting, RIGORS, REPORTS "HAVEN'T FELT THIS SICK IN YEARS". Narrative:
Extreme pain at injection site, fever,  headache, nausea, vomiting, metallic taste in mouth, muscle aches
Pt received Zostavax on 6/25/2008. Pt called today with c/o red rash with pustules on stomach and back. No fever. No itching, some discomfort to rash area.
A very small bump may appear on the skin in some areas but not always; Sporadic itching on various small, random areas of the body; have some redness; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:15 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included dermatitis contact (poison ivy/oak), temperature regulation disorder (temperature), hypersensitivity (Skin is sensitive to fragrance) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced on 09Apr2021 sporadic itching on various small, random areas of the body. No rash or swelling but will have some redness. A very small bump may appear on the skin in some areas but not always. The itching comes and goes but still persists after 2 weeks from dose 1. The clinical outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 10/01/2000 the patient developed 10-15 herpes zoster vesicles on her right hand. On 10/02/2000 the patient was seen in the physician's office. The vesicles were located on the patient's right side. There were 7 to 8 grouped vesicles over an erythematous base. The patient's maximum temperature was 97.9F. Pain was noted to be 4 on a 1-10 scale with itching. Additionally it was noted that the rash did not occur at the site of injection or elsewhere within 42 days of vaccination. A specimen was obtained for PCR analysis on 10/02/2000 and the results are pending. The patient's herpes zoster persisted. Follow up information indicated that the preliminary PCR was VZV positive. Final results are pending. Follow up information indicated that the final PCR result was positive for wild-type VZV. Additional information has been requested.
5/24 - nausea (zofran ODT) resolved 6/03 - nausea / vomiting (Zofran ODT) resolved; increased arthralgia (tramadol w/acet 1000mg QD PRN) improved not resolved, more prominent malar rash (no treatment) with moderate warmth at rash site; fatigue / malaise. (missed 2 days of work) 6/24 - moderate to severe arthralgia to major joints (increased tramadol w/acet to BID/PRN) improved, not resolved; n/v (Zofran ODT) improved but lingered; weakness, fatigue / malaise (missed 2 days of work) 7/12 - n/v (changed to zofran as ODT increased n/v), pain / arthralgia moderate to severe (tramadol w/acet 1000mg increased to TID PRN & methylprednisolone 4mg dose pack); Migraine headache x4 days unrelieved (Imitrex, Aleve, & Acet. rest
pt recv vax & devel diffuse,itchy hives,in addtl to an itchy & swollen throat;this is one of two patients from this site who exp the above rxn
On 3/26/99, the pt experienced stiffness and joint pain in the fingers of his right hand. He progressed to having arthralgia, and decreased flexion, and grip strength in the right arm. It was noted that the discomfort worsened when he squeezed his fist. The pt sought unspecified medical attention.
This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL. No adverse symptoms were reported. The temperature excursion for GARDASIL was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with GARDASIL. This case is related to MARRS# 1410USA015443, 1410USA015493 and 1410USA15944. Additional information has been requested.
Dizziness, Headache, Blurry Vision, Fever, Body/ muscle aches, joint pain, unable to drive/ function , and golf ball sized welt at sight of injection
Left leg was red, swollen to the size of a pop can and hot and hard to the touch. No fever. No SOB. This happened the next day at noon. Advised to use cold packs 3-4 times/day for 10 minutes.
COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number :3 (Moderna)/Vaccine dose number :2 (Pfizer); This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL9261), in left arm and on 10Feb2021 as dose 2, single (Lot number: EM9809) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Lot number: 022C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Chloresterol" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "neurocardiogenic syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephlosporin, reaction(s): "Known allergies: Cephlosporin"; Bactrim, reaction(s): "Known allergies: Bactrim"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "Vaccine dose number :3 (Moderna)/Vaccine dose number :2 (Pfizer)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 11Sep2022 and 16Sep2022.; Sender's Comments: Based on the information in the case, an association between the reported events vaccination failure and covid 19 and suspect product bnt162b2 cannot be ruled out.
Nausea started the day of the injection. Hives on the arm that she received the vaccine started the day after the injection.
sick; Initial information received on 23-Feb-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves patient (unknown demographics) who got sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE for prophylactic vaccination with reaction of sick (when everytime that patient got the flu shot got sick).  The patient's past medical treatment,  concomitant medication and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  Patient went 8 years without a flu shot and didn't get sick at all.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination (new doctor gave he/she a flu shot).  On an unknown date, the patient got sick (illness) for 1 week (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  It is unknown if the patient experienced any additional symptoms/events.  Medication details and reason for taking the medicine was not provided.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Patient received 3 Moderna vaccines on 2/4/21, 3/4/21, and 8/3/21. Patient presented to ED on 11/5/21 with acute on chronic DOE and chest pain (history of DOE and chest pain for 2 years and new diagnosis of HFpEF). Troponin was elevated and ECG was consistent with pericarditis. CMR confirmed myopericarditis. Troponin 369 -> 559, CK 867, CK-MB 17.2, CRP 36 and ESR 42. Patient was appropriately treated with indomethacin and colchicine.
Donor reported that he had a fever and nausea as well as what he described as " A spacey feeling" the day after his immunization at the donation center. He stated that his symptoms lasted 4 days and he did not report this information to us until 06/27/2023. Donor on this date reported that he was free from all symptoms and an internal donor adverse report was initiated.
Patient had pneumonia vaccine on Wednesday afternoon in clinic, and that evening developed pain in the arm.  She was unable to move it at all without significant pain.  Dull, bore-like pain.  Like a nerve pain in a tooth. She had some Norco left over from a tooth procedure and required that for pain relief. Yesterday she developed redness and warmth of the area.  She has used a "temporal" thermometer on the area and it was reading 99, compared to her normal body temperature of 98. The pain has improved since Wednesday night and she is able to move her arm more without pain.