chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GUILLIAN BARRE SYNDROME; This spontaneous report received from a consumer concerned 100 patients of unspecified age, sex, race and ethnicity. 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: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : This spontaneous report was received from a consumer and concerned 100 people who experienced Guillain Barre syndrome (GBS) an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history and concomitant medications were not reported. No other additional details regarding symptoms, diagnostics, treatment, or outcome were provided. Information is limited in this case, and the occurrence of GBS could represent background incidence of such events in the general population. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested.
A report was received from a health care professional on 10/31/03, concerning a 2 year old male vaccinee who was inadvertently administered Fluvirin on 10/31/03. The vaccinee had experienced no adverse effects at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update report 01/05/04: Follow up information received from a health care professional indicated that the female vaccinee was inadvertently administered 0.5ml of Fluvirin. Follow up pending.
This spontaneous report as received from a pediatrician via company representative refers to a 12 months old female patient. Information regarding patient's pertinent medical history, concomitant medications, drug reactions or allergies were reported as unknown. Information regarding patient's concomitant medication and past therapies were not reported. On 07-MAR-2018 the patient was vaccinated with first dose of M-M-R II, subcutaneous in the right vastus lateralis, lot # N019126, Expiry date: 22-JUN-2019 also reported as unknown for routine vaccination (dose was not reported).Other suspect therapies included VARIVAX (therapy start date: 07-MAR-2018, first dose, subcutaneous in the left vastus lateralis, lot #N017397, expiry date: 07-JUN-2019 for prophylaxis whose dose was not reported). On 19-MAR-2018, 13 days after onset of therapy the patient "broke out in a bright red rash on cheeks (Rash erythematous). On 21-MAR-2018, the patient developed a fever of 100.8 degree F (pyrexia), cranky (Irritability), cried for 14 hours, holding head (head discomfort), cheeks erythematous, diffuse red raised bumps to trunks and extremities (rash papular) for which the patient was brought to an outpatient clinic, emergency room and then to pediatrician's office on the same day. On an unspecified date, the patient had underwent strep test which showed negative. On an unspecified date, the patient had underwent platelet count evaluation which was found to be normal. Patient received an unspecified treatment for the adverse events rash erythematous and crying. No treatment was given for the adverse events pyrexia, irritability, cheeks erythematous, head discomfort and rash papular. The outcome of pyrexia, irritability, cheeks erythematous, head discomfort and rash popular was reported as recovered/resolved. The outcome of rash erythematous and crying was reported as recovering. The pediatrician thinks "rash is a from a reaction of the of M-M-R II vaccine. The pediatrician did not provide the causal relationship of events pyrexia, irritability, cheeks erythematous, head discomfort and crying with M-M-R II vaccine. The pediatrician did not provide the causal relationship of events rash erythematous, crying, pyrexia, irritability, cheeks erythematous, head discomfort and rash popular with VARIVAX. It was reported that "temperature excursion occurred as a result of reading from a digital data logger." There was no product quality complaint (PQC) involved.
ADMINISTRATION FROM PUNCTURED VIAL HELD LONGER THAN RECOMMENDED STORAGE TIME; PRODUCT STORAGE ERROR; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration from punctured vial held longer than recommended storage time, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration from punctured vial held longer than recommended storage time and product storage error was not reported. This report was non-serious.
Pt developed a temperature of up to 103.6, was taken to the ER with a temperature of 105.8. Pt was treated with Tylenol, Phenergen, and acetaminophen
p/vax pt c/o feeling dizzy & woozy, hot at 1045AM;had pt place head between knees, cold towel to forehead, coke to drink;pt then looked flushed, pulse 80 & regular;c/o tingling feeling in jaw area;to MD;
patient got flu; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional  This case involves patient of unknown demographics who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE, [flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got flu (influenza) 1 week following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
-Patient developed three ulcerous lesions (similar to canker sores) in her vaginal area.  One was a little larger than a pencil eraser and the other couple were smaller.  They were itchy and painful.  She noticed them on Sunday and we went to her medical provider on Wednesday. As of today, 1/17/2022, they are getting better and resolving but they have not yet healed completely. She has never had these before in her genital area and did not have this reaction after her first or second doses. There was no recommended treatment. -Patient's lymph node in her left armpit became swollen and noticeable on Saturday afternoon, 1/8/2021, maybe around noon. This was a new symptom which she did not experience after the first or second doses. -She had one canker sore in her mouth at the same time.  New symptom. -Her reaction after her booster also included a fever of 101.3, fatigue, vomiting, headache and bodyaches. This started around 05:00am on Saturday, 1/8/2021 and lasted until about 9:00 pm on Saturday 1/8/2021. Since she had a fever, vomiting, fatigue and aches after her second dose, we anticipated these symptoms after booster.  We treated her symptoms with Tylenol.
Patient wanted fluzone high-dose but was accidentally given the regular quadrivalent fluzone dose.  No adverse reactions reported.
severe headache; nausea; fatigue; chills; body ache; 100 degree fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 02Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and pain pelvic. The patient was allergic to melon and bermuda grass. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included lithium (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL) and levomefolic acid (METHYLFOLAT). The patient previously received PERCOCET for unknown indication and experienced drug allergy. 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 02Apr2021 at 15:00, the patient experienced severe headache, nausea, fatigue, chills, body aches and 100-degree fever. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events severe headache, nausea, fatigue, chills, body aches and 100-degree fever were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
3 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
Fevers up to 102.6°F the night and day after receiving second shot. Severe chills that caused my body to shake so badly I spilled drinks. Lasted about 40 hours. Improved with Tylenol and Advil alternating every 3-4 hours but returned as soon as medication wore off.
Started to feel sick; Started to feel chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started to feel sick) and CHILLS (Started to feel chills) 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 MALAISE (Started to feel sick) and CHILLS (Started to feel chills). At the time of the report, MALAISE (Started to feel sick) and CHILLS (Started to feel chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Awoken the next day with my skin from head to toe feeling as if it were on fire. The feeling of pinpricks all over my skin. Nerve pain all over my body. Joint pain even in my ribs. Radiating pain from my right arm across my back, neck, and down my left arm.
FEVER; ANKYLOSING SPONDYLITIS FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2022, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (FEVER). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and PYREXIA (FEVER) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis, who experienced the serious (medically significant) unexpected AESI Ankylosing spondylitis flare up, on an unknown date after receiving an unspecified dose of mRNA-1273. Pyrexia was also reported as a non-serious event. Clinical findings, diagnostic tests and treatment details were not provided. Patient´s medical condition remains a contributor factor for the event. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis, who experienced the serious (medically significant) unexpected AESI Ankylosing spondylitis flare up, on an unknown date after receiving an unspecified dose of mRNA-1273. Pyrexia was also reported as a non-serious event. Clinical findings, diagnostic tests and treatment details were not provided. Patient´s medical condition remains a contributor factor for the event. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
4 minutes after administration of 0.3 ml of Covid-19 vaccine pt experienced audible weezes and swelling of tounge as well as itching to tounge and throat.  Pt was administered .3 MG Epinephrine VIa Epi-pen auto injector to Left VL by RN @ 1510.  EMS called and Pt Transferred to ED.
Admission Date: 9/7/2022 Discharge Date: 9/8/2022  PRESENTING PROBLEM: Addisonian crisis   HOSPITAL COURSE: 65 year old male with past medical history of Addision's disease, developed a cough, fever, chills and sore throat on 9/6. He reports he missed his mornings pills because his throat was too sore to swallow. Later that afternoon he went to the ED for malaise. Covid-19 positive. He was found to be hypotensive, received 3L IVF, hydrocortisone and started on Norepi. Norepi weaned off upon arrival in the ICU.
Patient already vaccinated. First dose of Moderna vaccine administered 03/16/2021, second dose administered 04/06/2021 (21 days after first dose).   No adverse reaction or symptoms reported. Verified with MD that no other doses will be given.
Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was unable to drive  and not able to care for patients.
Headache, Myalgia, HYPERtension, chills Narrative:
diarrhea; Fever of 101; chills; very fatigued; some severe headaches; not felt very well; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 (at the age of 76 years old) as dose 2, single for COVID-19 immunisation. No medical history reported. Concomitant medications included gabapentin from Apr2020; diltiazem hydrochloride (DILT-XR) from an unspecified start date; losartan from Apr2020 and ezetimibe (ZETIA) from an unspecified start date - all ongoing and taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: not reported), via an unspecified route of administration, administered in left arm on 11Jan2021 at 13:15 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation and experienced very painful stiff neck and rapid heartbeat. On 01Feb2021, the patient had fever of 101 and chills overnight on the "1st to second" (as reported). The patient was then fine for a day then had the same thing overnight. On 04Feb2021, the patient had another fever of 101 and diarrhea. Furthermore, the patient reported to be "very fatigued" for the next week on an unspecified date in Feb2021. Since then, on an unspecified date in Feb2021, the patient had some severe headaches and have not felt very well since taking the second vaccine. Events did not result to emergency room nor physician office visit. Outcome of events severe headache and not felt very well was not recovered and unknown for the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes of vaccine she received a metallic taste in her mouth, arm, back, back head, feet and neck has been itching consistently, rash on back
Patient developed new onset right eye droop three days after the vaccine dose, was checked for serum antibodies for myasthenia gravis and was positive
Pt recvd 1 dose of Engerix-B & exp elevated liver enzymes (elevated SGOT & SGPT); pt is currently hospitalized; MD is investigating cause of liver enzyme elevation;
Induration over vaccine site, (site of Dtap and Prevnar on right thigh.
Injection site reaction; Injection site swelling; Injection site redness; Injection site itching; Injection site warmth; This spontaneous report as received from a other health professional refers to a 75 year old female patient with hypertension.    On 25-APR-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R024025, intramuscular for prophylaxis.    Concomitant therapies included losartan(LOSARTAN) and vitamins (unspecified)(VITAMINS (UNSPECIFIED)).   On 25-APR-2019, 1 day after onset of therapy the patient experienced injection site reaction, injection site swelling, injection site warmth, injection site erythema and injection site pruritus.    The outcome of injection site reaction, injection site warmth, injection site pruritus, injection site erythema and injection site swelling was reported as not recovered/not resolved.   The reporter considered injection site reaction, injection site swelling, injection site warmth, injection site erythema and injection site pruritus to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Severe, sudden nausea,  vomiting, & diarrhea dizziness. Was given booster 4 and flu vaccine at the same time. as a result she fell and hit her head, resulting in a brain bleed. Brain bleed spreading resulting in embolization, in addition severe calorie malnutrition due to lack of eating. Feeding tube was administered.
Hot, swollen leg at site of vaccination.  Originally, 1" diameter swollen firm site, now stretching to an irregularly shaped red swollen area up to 4.5" in diameter at widest point.
PT REPORTS THAT SHE BEGAN HAVING PAIN AND RANGE OF MOTION CHANGES IN HER ARM A DAY WITHIN GETTING HER INJECTION.
Pt received vaccination on date noted above. She subsequently developed sx of covid started 2/5/2021. tested + for covid infection 2/8/2021.  covid sx include fevers, myalgias, fatigue. pt did not report any s/e from vaccine. But I wanted. you to know she subsequently got infection after first vaccine. Thanks.
Pt vaccinated with DTP/OPV. Patient cried for two days after DTP. There was no local reaction & no temp.
No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat, couldn't wake him up and passed away.  The patient's medical history, as provided by the reporter, included high blood pressure and prostate cancer. No relevant concomitant medications were reported.   On 19 Jan 2021, the patient had a blood pressure reading of 133/84 at a cardiology visit.   On 13 Feb 2021, approximately 3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at 3:30 pm, the patient could not be woken up and was found with no pulse or heartbeat.   Action taken with the drug in response to the events was not applicable.  The outcome of the events, no pulse or heartbeat and couldn't wake him up, were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.   The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Next day resulted in localized redness, swelling, and sore arm. Has also started itching. Symptoms continued until at least 11-12-18.
Information has been received on 10/7/02 from a nurse concerning a 20 year old female patient that was vaccinated with Menomune A/C/Y/W-135 SC on 9/30/02. The lot number us UB229AA. Patient developed widespread hives, loose cough, lip swelling and throat tightness on 10/5/02. Patient was treated at the local urgent care with Benadryl, Prednisone dose pack, and Clarinex. Patient is recovering from the events. A 15-day follow up report received 9/30/2003 adds: From additional info received on 09/09/2003 from a health care professional, it was reported that the pt received Menomune A/C/Y/W-135 subcutaneously in the left upper arm. Treatment included Medrol dose pack, Benadryl and Clarinex. The pt was reported to be recovering from the events. AE coding was updated. From additional info received on 09/23/2003 from a registered nurse, it was reported that the pt had been seen on 10/06/2002 initially and "the only time" at the health facility. The pt was treated with Medrol dose pack, Benadryl and Clarinex and was released in stable condition. Reportedly, the pt returned later that same day with same complaints and was then treated with four milligrams of Decadron, given intra-muscular (1 x dose). The pt remained there for approximately 30 minutes for observation (facility policy after injections) and was then released. The nurse stated that she did not see any notations referencing the pt outcome, except that the pt did not have any reaction to the Decadron. Reportedly, the pt had a possible allergy to eggs in her childhood, concurrent medication is birth control pills. There has been no further contact or info regarding this pt. No further info is anticipated, this case is considered closed.
vaccine expired on 09/21/2021 was administered on 10/01/2021
This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced administration of expired vaccine (non serious, outcome: unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.