chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 65 y.o. male patient of MD.   Report on admission: This is a 65-year-old male with severe mental retardation and is nonverbal presenting to the emergency department for altered mental status.  Caregiver at the bedside reports that this morning when they tried to get him up he did not want to open his eyes.  She states that he did not want to take his medication and usually he is very good about it.  EMS was called and he was noted to have a blood sugar of 55.  He was given D50 and seems to be more responsive.  Blood sugar at the recheck is over 200.  Upon arrival to the emergency department he is noted to have a blood pressure in the 60s.  Hospital course as below.  Patient improved with medical treatment.  Patient discharged back to group home in stable condition.     1.  COVID, + 12/25/2022: -CT chest without pneumonia -Decadron -Patient back on room air, no indication remdesivir -Lovenox DVT prophylaxis  2.  Acute hypoxic respiratory failure: Resolved -Secondary to above -Wean oxygen as able  3.  Elevated troponin: -Cardiology consulted -ACS ruled out -No further work-up at this time  4.  AKI: Resolved -Monitor labs  5.  Sepsis trigger: -Received broad-spectrum antibiotics in ER -12/25 blood cultures no growth to date -Urine culture negative -Monitor off antibiotics  6.  Acute encephalopathy: -CT head nonacute  7.  Other chronic medical conditions: History of anemia, known aortic aneurysm, bladder incontinence, history depression, nonverbal, OCD, history of seizure, mental retardation
Fatigue,  chills and pain all over my body. Not sure about fever as I didn't have a thermometer. The symptoms got better yesterday but deteriorated again Sunday night.  It is now Monday morning, 9;48 pm est. and I am still feeling bad and having the symptoms stated above. I have been drinking orange juice and water and taking Tylenol  and nyquil. I am concerned about how long the symptoms are continuing and if I should be doing something different.
I BROKE OUT IN HIVES ON BOTH UPPER ARMS AND SHOULDERS AND ONLY A LITTLE IF ANY ON MY BACK AND CHEST. THE HIVE ARE ITCHY BUT I HAVE HAD NO PROBLEMS BREATHING AND AM TRYING TO CONTROL IT BY ANTIHISTAMINES. I HAVE NEVER HAD A REACTION LIKE THIS TO PREVIOUS FLU SHOTS.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 20-Jan-2013. The patient experienced expired FLUMIST QUADRIVALENT administered. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious. Corrected report 24-Feb-2014: Key ingredient of FLUMIST QUADRIVALENT was changed from FLUMIST to Q/LAIV.
Patient received the Pfizer vaccine (0.2 mL) and then walked to the observation area.  Within 30 seconds of sitting at the table, she looked up at her mom and said, "I feel tired".  She then passed out to the point of losing bladder control and wetting her pants.  Paramedics were called.  By the time they arrived, she was conscious again.  They checked her vital signs and monitored her for about 10 minutes.  She wasn't transported to the hospital and was able to walk out on her own (with mom) when her observation time was done.
Per provider on site: Patient received Covid 19 Pfizer vaccine approximately at 1:25 pm. She noted to feeling dizzy when she presented to my station about 15 minutes after her vaccine. She stated to having history of moderate asthma, carries albuterol with her. She denies drug allergy, but had lightheadedness with MMR vaccine in the past. I checked her pulse rate, 94 regular. 5 minutes later, she c/o feeling worse. She had inspiratory wheezing to auscultation, VS stable. BP 122/72, HR 103, pulse oximetry 99%. She had albuterol MDI inhaler with her, I asked her to self-administer 2 puffs. I administered 25 mg of diphenhydramine. She declined 50 mg because she gets very groggy to anti-histamine.  Approximately 3 minutes later, she noted to feeling like her throat is very dry and warm, almost difficult to swallow. She describes sensation like she is breathing thru a straw. Her vitals remain stable: BP 133/74, HR 128, pulse ox 98%. Throat without swelling, redness, no stridors noted, but she continues to have inspiratory wheezing. She declined to have Epi given.  I made decision to call paramedics given high risk for bronchospasm. Paramedics arrived approximately 7 minutes later. Vital signs remain stable. She continues to feel like she is "breathing through a straw." She is transported to ER
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-AUG-2015 the patient was vaccinated with 1 dose of GARDASIL Lot K010574, expiration date 08-APR-2017 (dose, strength, route unspecified) which was exposed to temperatures outside of the recommended range. The patient had not reported an adverse experience. No product quality complaint was involved. This case is linked to the cases 1508USA010363, 1508USA010628 via same reporter link. Additional information has been requested.
Since having the vaccine have been experiencing very irregular, heavy, and excessively long menstruation.; Since having the vaccine have been experiencing very irregular, heavy, and excessively long menstruation.; Administration date 07Apr2021, dose number 2, Administration date 21Apr2021, dose number 1; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 22-years-old non-pregnant female patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ENG6199), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 15:00 (at the age of 22-years-old) as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 15:00 (at the age of 22-years-old) as dose 2, Single for COVID-19 immunization. The patient's medical history included major depression, anxiety disorder (Verbatim: General anxiety disorder), endometriosis from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Patient had no know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, patient did not been tested for COVID-19. Since having the vaccine, the patient has been experiencing very irregular, heavy, and excessively long menstruation on 11Apr2021. Facility where the most recent COVID-19 vaccine was administered: Hospital. Outcome of events at the time of last observation was recovered/recovered with sequel and for inappropriate schedule of vaccine administered was Unknown.  Information related to batch/Lot no. was requested.
pt recv vax & end of JAN97 & a couple of days later devel arthralgia;pt also devel a low grade fever;sx lasted a couple of wk & resolved w/no treatment;
Sudden onset of pruritic papular vesicular rash to bilateral feet.  Over several days, spread to bilateral legs and arms (mainly extensor surfaces) and finally cheeks.  No involvement of trunk.
Starting on the way home, became nauseated, had body aches, and flu-like symptoms for 48 hours. Left arm swelling also.
No adverse effects; Improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a medical assistant referring to unspecified number of patients. The patients concomitant medication included sterile diluent. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies were not reported. On  unknown dates, the patients were vaccinated with doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S015459, expiration date 20-MAY-2021 (dose, strength, frequency, route of administration were not reported) for prophylaxis or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S012536, expiration date 20-OCT-2020 (dose, strength, frequency, route of administration were not reported) for prophylaxis, that had been improperly stored (product storage error). All lots of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no product quality complaint present. Both of the lots of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) went through temperature excursion of -11.5 Celsius degrees in the time frame of 47 minutes. There was no previous temperature excursion. The call was placed due to data logger.    This is a non-valid case as there are no identifiable patients (unspecified number of patients).  Follow up information was received from the medical assistant on 14-APR-2020. This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid.   The report concerned to a 14 month old male patient. No medical history, concurrent conditions nor concomitant medications were reported. On 17-OCT-2019 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Lot No. S015459, exp. date 20-MAY-2021) for prophylaxis. No adverse events reported.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2004USA004814: US-009507513-2004USA004815: US-009507513-2004USA004816: US-009507513-2004USA004817: US-009507513-2004USA004818: US-009507513-2004USA004819:
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 28 years old female patient who received vaccine IMOVAX RABIES.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Immunoglobulins Nos and Tetanus Vaccine for Immunisation along with three other unspecified shots. On 03 Dec 2018, the patient was bitten by monkey on her left forearm. Patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route along with Immunoglobulin and Tetanus toxoid by IM route. Patient was asked to received dose on 3rd day, 7th day and 14th day however she missed those because she was traveling. It has been 15 days since her last rabies shot. She has missed the rest of her Rabies shots. It was a case of actual medication error due to incomplete course of vaccination. It was unknown whether any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (I have had a dull headache ever since) 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 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (I have had a dull headache ever since). At the time of the report, HEADACHE (I have had a dull headache ever since) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that it was unknown about immunocompromised status of patient. No concomitant and treatment information provided.
Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Early, very much longer than usual, heavier and more painful menstrual cycle; Feeling terrible body aches; Migraines; Pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 29Aug2021 at 12:30 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 08Aug2021 at 16:30 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On 30Aug2021 at 07:45, the patient experienced early, very much longer than usual, heavier and more painful menstrual cycle as well as felt terrible body aches, pain and migraines. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early menstruation, very much longer than usual menstruation, heavier menstruation, more painful menstrual cycle, felt terrible body aches, pain and migraines were recovered with sequelae on an unspecified date in 2021.
Patient was given Kinrix as a 3rd dose of DTap and the 2nd dose of IPV. Patient did not have any adverse reactions at the time but the administration of the vaccine was off on the authorized usage for dosing schedule.
Growing rash, red hot painful injection site, severally painful and tender lymph node in right underarm.
Experiencing the following symptoms: fatigue, muscle pain, chills, nausea, and fever. Fever got up to 102 degrees. All side effects started occurring on Sunday June 13th around 1:00am.
Chills, Lethargy, Headache - chills and headache slowly faded within 24 hours of onset of events and the lethargy lasted a few days
PERIORBITAL ANGIOEDEMA, HIVES, GENERALIZED URTICARIA.  REQUIRED HOSPITALIZATION.  TREATED WITH PREDNISONE, ALLEGRA 180 AND BENADRYL.  AS OF 9 APRIL 2003 (18 DAYS AFTER VACCINATION), PATIENT STILL HAS A PATCH OF ELEVATED ERYTHEMA.
1145 MMR given pt started to cry & held breath until pt became unresponsive w/facial cyanosis;
chills; fatigue; This is a spontaneous report from a contactable consumer (Caregiver). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for covid-19 immunisation. Caregiver calling about client who received second dose of Pfizer covid vaccine on 22Feb2021. Client experienced chills and fatigue during the night on 22Feb2021. Caregiver asked how long symptoms usually last. The outcome of the events was unknown.  Information about the lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Jan2021 as dose 2, single (Batch/Lot number: unknown), on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing), the patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 12Jan2017; FINASTERIDE, start date: 01Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was treated with Paxlovid for Covid-19 treatment from 22Jul2022 to 27Jul2022. The reason for unknown lot number for all the doses of vaccine was misplaced/discarded.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
Enlarged lymph node on left side of neck at day 5 post vaccination. Still present 3 weeks later.
she started having congestion and 'noise' in her ears; she started having congestion and 'noise' in her ears; some inflammation of the vascular system or nerve in that area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: EAR CONGESTION (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "she started having congestion and 'noise' in her ears"; INFLAMMATION (non-serious), outcome "unknown", described as "some inflammation of the vascular system or nerve in that area". Therapeutic measures were taken as a result of ear congestion, tinnitus, inflammation.  Additional information: It was reported that the patient had seen a number of doctors and no one could help. The patient had tried steroids, antibiotics, physical manipulation in case it was a kinked nerve, had two wisdom teeth removed as source of inflammation. The reporter also stated that the patient did fine after the first vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tightness in chest after both shots, lasting several minutes.  large red circle at injection site both times, for several days.
Patient is under the age of 18 and received the Moderna vaccine instead of the Pfizer vaccine.
minor left chest pain, slight numbness in left wrist and hand; slight numbness in left wrist and hand; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received his unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 9266), via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 as a single dose for COVID-19 immunisation. The patient medical history diabetes, pancreatitis, heart problems (heart disorder) since unknown date. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. Concomitant medications included creon (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) started on unknown date within 2 weeks of vaccination and unknown if ongoing. The patient experienced minor left chest pain, slight numbness in left wrist and hand on 19Mar2021 at 10:00. The outcome of the events minor left chest pain, slight numbness in left wrist and hand were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
fatigued; little pinkness / red; swelling of arm; arm pain; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced fatigue, erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the fatigue, erythema of extremities, swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the fatigue, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient was told that he/she might be contagious to people who never had measles. The patient was very fatigued a day before reporting, but seem almost normal on day of reporting, with the exception of a little pinkness and swelling of arm (It was red a day before reporting, but did not hurt patient to the point that he/she couldn't sleep on it. The reporter did not give permission to follow up.
I ran a 104 degree fever that lasted 3 days, chills, body aches that lasted 1 week,  joint pain, cough that lasted for 2 1/2 weeks, headache that lasted  1 1/2 weeks, maliase that lasted for 2 weeks, and  shortness of breath that lasted 2 weeks but with random occurrances.
5 hours after vaccine - severe pain in shoulder. Loss of motion and strength also get with pain when raising arm or rotating shoulder. Pain does not respond to Tylenol or NSAIDS.  No swelling or inflammation visible.
Patient lied on intake form and indicated he did not receive previous vaccination.  Upon further investigation found pt received JJ on 4/9/21
vasovagal syncope. Occurred shortly after vaccine administration. Patient was faint, nauseous, and in a cold sweat for about 15 minutes after receiving the shot. Supplied water to the patient as requested. Patient recovered after 15 minutes and was fine with no remaining symptoms.
At the time of injection, I felt pain in the location of the injection. I then afterwards, continued to have muscle ache in that area, and a red rash began at that site, and around that entire area of the muscle area where the injection took place. The rash and ache still remain till today.