chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine that occured Sunday and Monday. I had a headache Saturday, but this transitioned to a migraine that lasted sunday all day and monday until about 12:00pm
Based on documentation from case manager's interview notes on 07/06/2021, "Advised of test results.  Client states he was asymptomatic when tested (pre-screening for a colonoscopy) and continues asymptomatic.  Client confirmed prior vaccination." Got tested on 07/03/2021.
The patient developed an erythematous, slightly raised, maculopapular  rash to her face and arms with mild itching that lasted about 2 weeks.
he has mild spot at the injection site its fading away; liquid around the injection site; big burst in his arm when he was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (liquid around the injection site), INJECTION SITE REACTION (he has mild spot at the injection site its fading away) and VACCINATION SITE PAIN (big burst in his arm when he was vaccinated) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 98D21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (big burst in his arm when he was vaccinated). On 29-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (liquid around the injection site). On an unknown date, the patient experienced INJECTION SITE REACTION (he has mild spot at the injection site its fading away). At the time of the report, VACCINATION SITE OEDEMA (liquid around the injection site) outcome was unknown, INJECTION SITE REACTION (he has mild spot at the injection site its fading away) was resolving and VACCINATION SITE PAIN (big burst in his arm when he was vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up information received on 05-Jun-2021 included new event injection site reaction and outcome of the event big burst in arm was updated from unknown to recovered/resolved; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
nausea; vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Since receiving Moderna shot #1 vaccine I have experienced three gout attacks. It is unusual for me to have this many gout attacks in such a short time period. Additionally, physical activity has been very challenging since receiving the shot.  I fatigue and become short of breath very quickly. During the first workout that I did, on 02/01/2021, after receiving the shot I became extremely dizzy, my eyes became light sensitive and my hands trembled; symptoms lasted for approximately 45 minutes.
Felt chills, cold, soon afterwards threw up once then diarrhea started (watery, 15 times thru Sunday) no fever at any time and then dissipated slightly. Head felt heavy. Less on Sunday. Monday felt better had a couple of meals, today diarrhea is trying to stop.
In late 2003 or early 2004 the patient began to notice balance problems, difficulty running and foot pain. He is unsure of the exact date of onset of symptoms but they became significant enough that he sought evaluation by a podiatrist in Apr 04. Severe pes cavus and brisk reflexes were noted prompting neurologic referral. One year later he was seen by neurology. At that time symptoms included awkward running, feelings of "falling over", difficulty standing on 1 foot, myoclonic jerks, intermittent tremor, occasional dysphagia, and difficulty holding items. A brain MRI, EMG/NCS and LP were normal. A diagnosis of SCA was made when Athena diagnostic tests were sent for analysis as well as SCA panel which returned positive for SCA 8 repeat expansion.  Symptoms: Gait abnormality, Weakness, Hyper-reflexia. 10/13/08-records received for DOS 8/13/08-follow-up visit after development of spinocerebellar ataxia first presenting in 2003. Balance problems in late 2003. Anthrax vaccine 11/12/03, 12/1/07 and 3/9/08, began to have foot pain with abnormal reflexes and tremors in feet. April 2005 seen by neurologist, genetic testing performed found to have SCA8. Currently condition has worsened in that now has difficulty typing and writing, gait is abnormal, tremors in hands, muscle wasting in legs, balance problems, falls, chronic fatigue.
DIARRHOEA; PAINFUL ARM; HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced painful arm. On 19-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhoea, and the outcome of painful arm and headache was not reported. This report was non-serious.
Patient given dose 2 weeks after vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Shingrix was second shot.  Chills, fatigue, headache, dizziness, lack of appetite, severe pain at injection site.  Lasted two and 1/2 days.
Severe pain; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Treatment details were not reported.
patient reports pain radiation across upper body and up neck, temperature of 101.0, and shivers.   She took a Percocet  that night for the pain and symptoms resolved within a day.
On 2/15/10 patient got hives around the abdomen, 8 hrs late it was covering the entire body from tip of scalp to palms of hands, feet, back, stomach w/ chest tightening. Patient took Prednisone 20mg x5 days then taper and started to recover.
Site swollen-six inches in diameter read, very warm to touch starting 10 mins after injection. Treated w/ice, Ibuprofen.
Developed shoreness in the mouth similar to cut. Visited Primary  care physician, was referred to ENT specialist, in turn referred to Oral medicine center, Dr. did biopsy of skin in the effected area of mouth. Established Lichen Planus. Treated by Dexomethosone rinse, and Clotrimazole  for 4 months with various dosages. Did not work. Lately about 2 months ago developed fungus like blister appearing and disappearing  in the moth. Still suffering from the same episode. Very difficult to eat and dring hot liquid.
Non localized pain and soreness of injection site. Patient had pain and soreness in his armpit and across his entire upper arm beyond injection site.
I received my flu shot at approximately 9:00am on 9/26/09. I had no illness at the time of the vaccination. About 10 seconds after the vaccination I developed mild nausea and a mild non-migraine headache. About 2 hours later I developed a sore throat. That same day the nausea and headache subsided. Later that same day and all day on 9/27 I had severe malaise. On 9/28/09 I developed a migraine. I took acetaminophen (TYLENOL) for treatment on 9/26 and 9/27, and I took 2 ibuprofen (ADVIL) tablets on 9/28. I still have a migraine.
Info has been received from an MD concerning a 6 y.o. male PT w/asthma and down's syndrome, who in 96 and 98 was vax'd w/a 1st and 2nd dose of Hep B vax recombinant, respectively. Concomitant therapy included nebulizer treatments for asthma. Subsequently, the PT developed alopecia areata. Unspecified medical attention was sought. Add'l info has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX reported as (vial 19,400 unit 1 standard package vial of 1) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored ZOSTAVAX was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received a PCV 13 when he shouldn't have.  No adverse events to report!
pain in joints in palms, fingers, ankles, & toes;pt had x-rays, bone scan, blood work;took Ibuprofen, Daypro, Darvocet;
Severe vomiting, diarrhea, chills. Have had flu shots for years and this was first reaction. Lasted 2-3 hrs at home.
COUGH, SOB, CHILLS, MUSCLE PAIN, HA, FEELING TIRED/SICK
Admitted on 8/23 with hypotension from dialysis, initial COVID 19 Antigen (-).  Underwent MRT on 8/31 and found to be COVID 19 POS
Shingles in right upper arm (just seems to be a strange coincidence that it was the exact location of the vaccine.) symptoms are: painful, pruritic rash right upper arm. Lesions are cluster of  6-7 erythematous papules and vesicles.
MENVEO comes as 2 parts (CYW-135 liquid and Men-A lyophilized) which are to be mixed prior to administration, stated in package insert and on vial. The liquid portion only was sent to pharmacy from another pharmacy. 2 pharmacists checked the medication and sent it to the ICU. 2 RNs were involved with administering the vaccine. Only the liquid CYW-135 portion was given, not the men-A portion. On further review of package insert information one of the satellite pharmacists noted the error and it was confirmed with nursing. We contacted the company regarding the vaccine components and need to redoes the patient. Serotype A of N. meningitides is rare and therefore, unless travel is planned, the CDC does not recommend revaccinating patients that only receive the CYW-135 portion of the vaccine. There are no clinical trials looking at the CYW-135 portion alone.
Mom called 2 days after vaccines given to report both child's arms red, swollen and warm to touch. Advised cool compresses, TYLENOL, call if no improvement.
Mother called 06/19/02. Stated right shoulder swollen; twice normal size. At 5:11pm 06/19/02 mother stated ROM decreased swelling and soreness but ADL's WNL. On 06/20/02,  pt examined by FNP, right arm=2.5inches in diameter with 20x20mm induration to upper right arm.
slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESTRADIOL from 08-Mar-2020 to an unknown date and ALENDRONATE SODIUM from 03-Jan-2018 to an unknown date for an unknown indication.   On 02-Mar-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to MOD-2021-066487 (Patient Link).
Pain at injection site, 50 cent size, pink + hot. Pain down arm up back of neck, Ice park topically, Declines Benadryl makes her drowsy. 11/01/2002  client out wk, States went home, took Benadryl,  Red area did not not increased in size. Tired with soreness in neck & arm.
(L) arm swelling, painful to touch reports got "red blotches" or "hives" at site of injection.
Altered mental status and seizure like tremors, slurring her speech, could not state day, time, place, or situation, salad like statements, increased weakness.
sickness; Difficult to breath; Increased pressure behind eyes; Obturator nerve swollen; Left eye optic nerve problem; Low blood pressure; Headache; Initial information was received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient (101.8 kg) who experienced sickness, difficult to breath, increased pressure behind eyes, low blood pressure, obturator nerve swollen, left eye optic nerve problem and headache after receiving influenza vaccine and while treated with selexipag, macitentan, digoxin, acetazolamide and furosemide [Lasix].  The patient's past medical history included Pulmonary arterial hypertension. The patient's past medical treatment(s) and family history were not provided.  Concomitant medications included riociguat (Adempas).  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for flu vaccination.  On an unknown date, the patient started taking selexipag Tablet 3200 ug (1 time every 0.5 day) of unknown strength via oral route (with lot - 124898402, 31-Aug-2023) for Pulmonary arterial hypertension.  On an unknown date, the patient started taking macitentan Tablet of unknown dosage, strength and frequency via oral route (with an unknown batch number and expiration date) for Pulmonary arterial hypertension.  On an unknown date, the patient started taking digoxin Tablet 100 mg once daily (QD) of unknown strength via oral route (with an unknown batch number and expiration date) for Product used for unknown indication. On an unknown date, dosage was changed to 300 mg once daily (QD).  On an unknown date, the patient started taking acetazolamide for Optic nerve disorder and lasix (furosemide) for Product used for unknown indication (form, strength, dose, frequency, route, lot number, expiration date, indication: unknown).  On an unknown date the patient developed a non-serious events sickness (illness),  difficult to breath (dyspnoea), increased pressure behind eyes (intraocular pressure increased), low blood pressure (hypotension), obturator nerve swollen (nervous system disorder), left eye optic nerve problem (optic nerve disorder) and headache (unknown latency) following the first and last dose intake of selexipag, macitentan, digoxin, acetazolamide, furosemide and influenza vaccine.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [96/71]; on an unknown date:  [94/76 mmHG]  Action taken with influenza vaccine was not applicable and with selexipag, macitentan, digoxin, acetazolamide and furosemide was unknown.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events sickness, difficult to breath, increased pressure behind eyes, obturator nerve swollen, eye optic nerve problem, was Recovered / Resolved on an unknown date for the event low blood pressure, and headache.
PATIENT RECEIVED SECOND DOSE OF SHINGRIX ON 2/8/2019 AND CAME INTO THE PHARMACY TODAY, 07/10/2019, REORTING SHE HAD AN ADVERSE REACTION TO THE VACCINATION. SHE DID NOT HAVE ANY ADVERSE REACTIONS TO THE FIRST DOSE, BUT 12 HOURS AFTER RECEIVING THE SECOND DOSE THE PATIENT STARTED HAVING CHILLS, FEVER, STOMACHE, AND AN ELEVATED HEART RATE OF 122 BPM. SHE SAID IT HIT HER ALL AT ONCE AND MADE IT SO SHE WAS UNABLE TO SLEEP. SHE WAS VERY WORRIED ABOUT HER HEART RATE. SHE STATED AT 9:00AM THE NEXT MORNING (2/9/2019) EVERYTHING STOPPED AND SHE WAS FINE.
stroke; Initial information regarding this unsolicited valid serious social media case received from a consumer (daughter-in-law of the patient) and transmitted to Sanofi on 18-Nov-2020.  This case is linked to cases 2020SA331005 (husband) and 2020SA330951 (father).  This case involved a female patient who had a stroke (cerebrovascular accident), while she received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was reported that the patient had 5 years with no sickness and very good health.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a serious stroke (cerebrovascular accident), less than a month following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant as per important medical event (IME) list.  Flu shots are dangerous.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: Sanofi company comment dated 27-Nov-2020: This case concerns a female patient who presented with cerebrovascular accident after vaccination with INFLUENZA VACCINE. The time to onset is compatible. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Why was the patient taking Covid-19 vaccine (Verbatim): because she is diabetic; swelling under eyelids; swelling on chin and left cheek; had an allergic reaction with  a rash; rash from neck up on chin and cheeks; This is a spontaneous report from a contactable reporter(patient herself). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in right arm on 29Apr2021 at 14:30 as single dose for COVID-19 immunization. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. AE(s) following prior vaccinations was reported as none. Medical history included type 2 diabetes mellitus. It was reported that she ran out of medication and was not taking anything for diabetes.  Family Medical History Relevant to AE(s) included that her father had a positive result after getting the vaccine. Her father has rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. Her father also had a rash on his arm that cleared up after getting the vaccine. No relevant tests were done as reported. Concomitant medication included Azo from 27 Apr 2021, ongoing and Nervive taken for nerve relief from 27 Apr 2021 and stopped taking it on 03 May 2021. It was reported that she was fine but had an allergic reaction with a rash from her neck up that was on her chin and cheeks around 1700-1800 on 29Apr2021. She had swelling under her eyelids on 30Apr2021 and on the bottom of her cheek on 30Apr2021. It was also reported that the patient took Covid-19 vaccine because she is diabetic. She was scheduled to get the second injection today(20May2021) and was asking if she should get it. She mentioned that she does not have a physician. She thought she had a reaction to it. Lot 1069C95021, Expiry Feb 2023.. The outcome of the events, off label use was unknown and rash from neck up on chin and cheeks and swelling on chin and left cheek was recovered on 11May2021, rash from neck up on chin and cheeks was recovered on 03May2021.  Follow up attempts are needed. Further information has been requested.
Patient was given a Hepatitis A (Vaqta) vaccine that expired on 03/02/2023.
I have had tinnitus for many years, however 24 hours after receiving my 2nd bivalent Covid vaccine the tinnitus became significantly worse.  I have an appointment coming up with an audiologist for testing and treatment and also an appointment with my ent provider.  I also have a hearing loss that occurred. A couple months after receiving my  3rd Covid vaccine.  I have filed a separate Baer?s report  temporary Vader?s e-report number 967105