chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart flutter; random rapid heart beat; Comstipation lasting a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; LEVOXYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 11Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 15Dec2021, outcome "not recovered", described as "Heart flutter"; HEART RATE INCREASED (medically significant) with onset 15Dec2021, outcome "not recovered", described as "random rapid heartbeat"; CONSTIPATION (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Constipation lasting a month". The patient underwent the following laboratory tests and procedures: heart rate: (15Dec2021) rapid. Therapeutic measures were taken as a result of cardiac flutter, heart rate increased, constipation and included treatment with Laxatives and Valium. Clinical Course: It was reported that the patient did not take other vaccine in four weeks. No Covid prior to vaccination. Covid tested post vaccination was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Child started vomiting 1 1/2 hr after shot and continued to vomit every 15 minutes from 2:30 - 6:30 pm and gave emetrol and vomiting stopped.
sick for 1 and half days after getting this year flu shot; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of unknown demographic who was sick for 1 and half days, while the patient received Influenza vaccine.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (batch number, expiry date route and administration site not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) after administration of Influenza vaccine the patient was sick for 1 and half days (illness).  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product concerning an 18 year old female patient, with a history of Chlamydia infection and on marijuana and tobacco use, morbid obesity and no drug reactions or allergies who on 02-DEC-2010 was vaccinated with her first dose of GARDASIL (Lot # and expire date not reported), 0.5 ml, intramuscularly. Concomitant therapy included azithromycin. Licensed practical nurse stated that on 21-DEC-2010, urine and blood tests were performed to the patient and they were positive. Licensed practical nurse also stated that the same day the patient had her first obstetrics appointment. Licensed practical nurse added that on 22-DEC-2010 a Chlamydia test was performed and was negative. The patient's last menstrual period was on 12-NOV-2010 and the estimated delivery date is on 19-AUG-2011. Follow up information has been received from a completed questionnaire from a physician concerning a healthy female patient with no previous pregnancies. Concomitant therapy included prenatals, azithromycin, DIFLUCAN, and ampicillin. The date of last menstrual period was on 12-NOV-2010 and estimated delivery date was on 20-AUG-2011. The patient went for prenatal care on 21-DEC-2010. Follow up information was received from a licensed practical nurse who reported that the baby was delivered in May 2011 at 27 weeks. The nurse indicated that the patient was pregnant again. At the time of the report the patient's outcome was unknown. Upon internal review, the baby was delivered at 27 weeks was determined to be an other important medical event. The baby's experience has been captured in WAES # 1101USA00115B1. Additional information has been requested.
Your were for your period for 23 days up to date and you are not pregnant. At my first dose my period was bleeding a lot. A saw a doctor and got a pregnancy test and have to go back one week to get more tests done.
2 days after receiving Typhoid & TDAP pt developed pruritus, then rash on bilat AC & torso - no H/O eczema.
FEBRILE CONVULSION; ADENOIDAL HYPERTROPHY; PYREXIA; C-REACTIVE PROTEIN INCREASED; NASAL CONGESTION; A spontaneous report has been received from a consumer via the regulatory authority concerning a 2 year old female patient.    No medical history was reported. No concomitant products were reported.    On 07-Dec-2021, the patient started receiving a treatment with Fluenz Tetra (influenza vaccine live reassort 4v) 1 df daily, via nasal route. No malfunction has been reported for Fluenz Tetra.    On 08-Dec-2021, the patient experienced febrile convulsion (preferred term: Febrile convulsion), adenoidal hypertrophy (preferred term: Adenoidal hypertrophy), pyrexia (preferred term: Pyrexia), c-reactive protein increased (preferred term: C-reactive protein increased) and nasal congestion (preferred term: Nasal congestion).     It was unknown if any action was taken with Fluenz Tetra.  At the time of reporting, the event of febrile convulsion, adenoidal hypertrophy, pyrexia, c-reactive protein increased and nasal congestion was ongoing.     The events were considered serious (hospitalised) by the reporter.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUENZ TETRA  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Febrile convulsion, adenoidal hypertrophy and C-reactive protein increased are not listed in company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Pyrexia has been associated with use of LAIV in children but not in adults. This case concerns a 2year old female patient with reported event of pyrexia in association with use of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Pyrexia could be contributory factor for the event febrile convulsion which could be in association with C-reactive protein increased. Due to limited information on exact circumstances leading to the event, treatment provided, concomitant medications, risk factors(allergy, infection), relevant medical and family history, concomitant diseases, detailed etiological and diagnostic workup (complete blood count, allergy work up, infection workup), the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the events and Quadrivalent live attenuated influenza vaccine (Q/LAIV).
Vaccine (ZOSTAVAX) administered at 8.20am (approx) on 9/19/13 3 mins later client c/o numbness in roof of mouth and back of tongue also dry mouth and dizzy. Vitals remained stable client remained in room 25 min no symptoms passed. No further treatment - left alert and oriented with daughter.
Slept most of the day; very lethargic; low fever (99.9); arm sore; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 25Mar2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 04Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced arm sore the day of the second vaccine. The next day the patient had a low fever (99.9) and felt very lethargic, slept most of the day with an on and off fever. However, the next morning the patient felt fine and no longer had a fever. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events arm sore, low fever, very lethargic and slept most of the day were recovered on an unknown date at the time of report.    No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.  No follow-up attempts are needed. No further information is expected.
suspected vaccination failure; shingles; spreading rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Shingrix for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and generalized rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and generalized rash were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient thought, he/she might get shingles after receiving Shingles vaccine. He/she had an increasingly spreading rash over body. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Patient called on 8-11-14 and said had two red quarter sized circular areas around injection site. She said it started itching on 8-10-14 and found red areas on 8-11-14.
ARM IN A KNOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm in a knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm in a knot was not reported. This report was non-serious.
Pt recv vax on 6/25/97; post vax pt exp optic neuritis of right eye
Patient felt lightheaded and had already left observation area 10 minutes earlier than her 15 minute recommended timeframe.  She sat herself down due to feeling of syncope and stayed with EMS to lay down for 20-25 minutes.
Daily intermittent headaches, fatigue, lethargy. Hospitalized 07-1-09 thru 07-6-09. IV TORADOL/COMPAZINE/BENADRYL with no relief. Currently being evaluated.  9/29/09 Neurology Consult (Pediatric Headache Program) received DOS 7/1/09 to 7/20/09. Assessment: New daily persistent headaches of unknown etiology. Patient began to experience a daily headache approximately 3 months ago. Also had cough and sinus congestion which have resolved. Headaches are bitemporal and frontal and throbbing. Phonophobia. Labile affect. Decline in grades, teased at school and has no friends. High arched palate. Nasal voice. 6 days inpatient IV DHE administration. After discharge difficulty sleeping. Profuse vomiting.
Patient was given Arexvy subcutaneously instead of intramuscularly by mistake.  The day after vaccination, patient had soreness, redness, joint aches in both arms and diarrhea off and on through Day3 after vaccination.  As of Day 3 the redness, soreness and joint aches had resolved and only mild diarrhea was ongoing.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported different events for two patients. This is the 2nd of 2 reports. A female patient of an unspecified age and race/ethnicity received TRUMENBA (NDC# 0005-0100-01), via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a 102 fever on an unspecified date with outcome of unknown.
Ovarian cyst ruptured; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8730) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Beta-thalassemia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "COVID-19", start date: 11Dec2020 (unspecified if ongoing), notes: Patient had COVID-19 prior to vaccination. Concomitant medication(s) included: CLONAZEPAM; ESCITALOPRAM; MUSHROOM COMPLEX [ALLIUM SATIVUM;GANODERMA LUCIDUM;HERICIUM ERINACEUS;INONOTUS OBLIQUUS;LENTINUS EDODES]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER2613, Anatomical location: Left arm), administration date: 17Mar2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset Aug2021, 5 months after the suspect product(s) administration, outcome "not recovered". The event "ovarian cyst ruptured" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2020) Positive, notes: Other. Therapeutic measures were taken as a result of ovarian cyst ruptured.  Clinical Course: Clinical Course: It was reported that the event occurred approximately 5 months after first Pfizer vaccination series and the patient did not have any cysts prior. The patient did not have nay known allergies and did not receive any vaccines four weeks prior to Covid vaccination. It was also reported that Tramadol was taken as treatment for the event Ovarian Cyst Ruptured.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event OVARIAN CYST RUPTURED and the suspect drug  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202300185261 Same reporter, patient, product, different doses and events;
I had the strange side effect; lips tingling; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Sep2021 at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 25Sep2021, the patient had the strange side effect, lips tingling. The patient after receiving the first dose of vaccine left the vaccination center, but they said to stay for 50 minutes. The pateint's whole family received the COVID Vaccination but only the patient had the strange side effect and was not sure if it was real or not and if anyone had complained about lips tingling right after the COVID Vaccination. The patient was not interested in filing any report, but just called to ask if it was a common side effect. The outcome of events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
SUPER EXHAUSTED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced super exhausted. The action taken with covid-19 vaccine was not applicable. The outcome of super exhausted was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539039 and 20210539060.
Breakthrough case admission after 3 vaccines  Moderna 2/13/21 lot# 016m20A;  Moderna 3/3/21 lot# 044A21A;  Moderna 11/22/21 lot# 012H21B
I had two menstrual cycles in quick succession with spotting in between. The first started on 4/9 and was not out of the ordinary except that spotting continued, then a second started on 4/22.  I would normally have cycles no sooner than 21 days apart.
Fatigue, feeling "run down" and body aches, negative flu swab in clinic, advised TYLENOL/MOTRIN and BENADRYL for symptoms and go to the ER if worsening.
Generalized hives Benadryl injection 12.5 mg stat and observation, hives disappeared in about 25-30 minutes after injection of Benadryl.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Headache, NauseaVomiting, Fatigue Narrative:  Other Relevant History:
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering.  No follow-up attempts are needed; No further information is expected.
Sudden onset of what felt like a deep respiratory illness similar to bronchitis. Included coughing, hoarseness, and a feeling of tightness in my chest when I breath. I did not take any treatment or seek medical attention. I drank a lot of water and went to bed and it was gone by morning. I didn't connect it to the flu shot until now but it was very strange to have an illness come on so strong and so quickly and then to be gone just as fast. I had the DTAP vaccine at the same time as the flu shot earlier that afternoon.
Almost 10 year girl w/asthma presents 1 day after receiving GARDASIL #1, MENACTRA, and BOOSTRIX. Mom states 3 minutes after arriving home pt's eyes started to swell up and turn red. Her arm also start to swell and turn red. This is the arm where the GARDASIL vaccine was placed (the right arm-- MENACTRA and BOOSTRIX were placed in the left). Mom gave dye free children's BENADRYL 5 ml x 1 and the swelling around the eyes and eyes improved. Overnight Patient started coughing. History of vomiting, abdominal pain, fever. Some SOB. Mom brought patient to clinic 3/30/2011.
This is a 59y.o. male PMHx CABG 2019, MS, DMII, HTN, HLD, moderate persistent asthma, neuropathy presents with 1 day s/p seizure.  Patient was diagnosed with COVID 19 on 11/16/2021 and was at home recovering. Patient's granddaughter was having her online school lesson when she noticed her grandfather on the couch shaking uncontrollably.  The granddaughter, who is 7 years old, called her mother.  EMS was called and noted the patient to be postictal and confused. Patient presented to ED where he experienced another tonic-clonic seizure lasting about 30 seconds that was witnessed by EMS and nursing staff. Patient has no history of seizure disorder. Patient has had 2 follow-up visits with his PCP per curbside car visit.  The family have been concerned because the patient's POx was 88-90% RA and the patient was encouraged to present to the hospital, but refused. The PCP told the patient to follow-up in the office in a few weeks. Patient was fully vaccinated for COVID, but lapsed for the booster.     The patient is currently alert and states that he's been taking his Trulicity DMII medication as prescribed. The patient denies subjective fevers and chills. Patient denies tobacco dependence, no alcohol abuse, no drug abuse. Patient denies chest pain, no shortness of breath. Patient denies cough, no congestion. Patient denies abdominal pain. Patient endorses overall MS and osteoarthritic pain.