chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had awful reactions; Took everything that I had to get up to get something to eat and go to the bathroom.; sick for 2 weeks; diarrhea; high fever; vomiting; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea) and PYREXIA (high fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache). In March 2021, ILLNESS (sick for 2 weeks) had resolved. At the time of the report, VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported. Patient stated that she received her vaccine in her left arm shoulder deltoid muscle.   This case was linked to MOD-2021-435845 (Patient Link).
I began having chills, a low-grade fever, sore muscles and soreness at the point of injection at 9 PM on the day of the injection. All of the symptoms except soreness at the point of the injection wore off at about 6 AM the following day. The soreness at the point of injection wore off later the following day.
It was reported the patient had a DVT; pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) and PULMONARY EMBOLISM (pulmonary embolism) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) (seriousness criterion medically significant) and PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) and PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  On an unspecified date of 2022, patient was administered with first booster dose of Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a female patient of an unspecified age, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Deep vein thrombosis and Pulmonary embolism that occurred after receiving the mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. It was reported that patient had a Deep Vein Thrombosis and pulmonary embolism 8 weeks after the second Moderna booster. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.
1/1/2021 - Experiencing headache, feeling weird all over.    Tightness in chest.   comes and goes.   Will call Doctor on Monday if still feeling the same.
Chills, severe pain at injection site worse day of injection and two days after. Unable to use right arm at all. Afebrile,all over joint pain.
Symptoms: Hypertensive Anaphylaxis onset within 30 seconds of shot. Face flushing, nausea, confusion, dizziness, high heart rate, hypertension, sweating, throat tightness, headache. IV Treatment: 125mg solumedral; 25mg dyphenhydramine; zofran Episode resolved within 20minutes of receiving the treatment. However, had a rebound of Anaphylaxis the next day 03/20/2021. Same treatment as before but had to increase to 50mg dyphenhydramine and also get dexamethazone. Took about 4 hours to resolve.  Preventive treatment after 2nd episode is to take dyphenhydramine 25mg every 4 hours for 2 days to give my body time to let the episode pass.
Within 2 days (not sure if it started on the first or second day) I noticed a spot on my left breast that expanded and appeared to have a streak that progressed to my armpit.  The first doctor ordered Doxycycline after consulting on the phone.  The next day the doctor at Facility said it was an emergency and treated me with cephalexin 500 mg/4 times a day.  A week later a spot appeared on the right breast and sent out a streak.  I went to the emergency room and they switched the antibiotic to Clindamycin.  However that did not appear to work and I was switched to cephalexin again.  I was seen at Facility for possible inflammatory breast cancer but the doctor felt it was not breast cancer related.  A third spot appeared but did not progress as the other spots did. I also saw a dermatologist who had no explanation for this condition but called it lymphangitis.   Almost a month later I still have the streak on my right side and remnants of the spot on the left side.  The doctors all seem to feel that this was possibly caused by the Shingrix vaccine.  Each spot started as a red spot about the size of a mosquito bite and progressed to a much larger area with streaking.  The third spot remains a small red spot with a white center.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005973; expiration date 02-FEB-2018) 0.5 ml, subcutaneously. There was not product quality involved. Concomitant medication was not reported. Additional information has been requested.
CHILLS; LEGS HURT; HEADACHE; TIRED; This spontaneous report received from a patient concerned a male 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 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced legs hurt. On 2021, the subject experienced headache. On 2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, tired, and legs hurt. This report was non-serious.
Information has been received from a physician concerning a female who was vaccinated with the first 0.5 ml dose of GARDASIL (no lot number provided). The patient developed hives a few days after the vaccination. The hives did clear up but broke out again after a few weeks. The patient had not received the second dose of GARDASIL yet which was why the physician believed her experienced was not related to the GARDASIL. Unknown medical attention was sought. At time of reporting, patient outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Admitted 10/5/21 to Hospital. Intubated 10/19. Discharge Dx: Acute hypoxic hypercarbic respiratory failure due to COVID PNA, COVID PNA with ARDS, AKI d/t ATN, pneumomidiastinum, uremic bleed, aspiration and neumococcal PNA, acute thrombocytopenia, liver cirrhosis. Changed to comfort care and terminally extubated 10/25/21
pretty sick Friday and Saturday; This is a spontaneous report from a contactable female consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 at a 1st dose, single dose for COVID-19 immunization. Medical history included arthritis (patient takes Aleve, occasionally, for arthritis). Concomitant medication included naproxen sodium (ALEVE) taken for arthritis. Reporter is a patient who received her first dose of Pfizer-Biontech Covid19 vaccine this past Thursday, 04Mar2021. Patient takes Aleve, occasionally, for arthritis. Patient needs to wait a week after vaccination before she can take anything like Aleve, per the CDC website. The patient experienced pretty sick Friday and Saturday on an unspecified date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient's blood pressure and it was 140 over a 100; not feeling good; felt kind of weird; felt kind of chills; felt like she wanted to faint, she felt little dizzy; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 03Aug2021 (Batch/Lot number was not reported; at the age of 27 years old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia and blood pressure (abnormal). Concomitant medications included duloxetine; pregabalin; labetalol; and other unspecified medication, all for blood pressure. The patient received her first Pfizer vaccine today (on 03Aug2021, pending clarification). The patient told her husband that she was not feeling good and felt kind of weird. The patient also felt kind of chills. So, the patient's husband came and checked the patient's blood pressure and it was 140 over a 100 and pulse was very close to 80. The patient took blood pressure pills at nighttime and it helped some. The patient felt like she wanted to faint, she felt little dizzy earlier she was holding the baby. The patient's husband is wondering whether it was side effects of the vaccine or if was because of her blood pressure condition. The reporter confirmed that the patient experienced the events probably about 05:30, about 2 hours after she received the shot. The patient is still experiencing the events. The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
I63.9 - Cerebral infarction, unspecified CEREBROVASCULAR ACCIDENT
The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022; The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) and PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) and PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported as nurse states that they administered 5 doses on 24 Mar 2022 of the Moderna Covid-19 Vaccine to 5 patients after the manufacturer date of expiry (29Jan2022) from a single vial,.  Date the vial initially stored in the refrigerator 07-Mar-2022. The vial had not undergone any temperature excursions.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter
Started as sore throat, cough, sneezing, and extreme fatigue.  This lasted about 2 weeks, treated with Robitussin and Ibuprofen.  Did not consult doctor until later.  3/1, I sought doctor advice as I was feeling fatigue linger and was not myself.  I was diagnosed with Long Covid.  No treatment offered from Doctor.
headache day of injection 8/18, ear discomfort and sudden hearing loss 8/19 to R ear. appointment with PCP 8/20. appt with ENT specialist 8/24, prescribed prednisone. appointment with audiologist 8/24. apointment with ENT specialist and Audiologist 9/8. MRI ordered and done 9/10. appt 9/11 with ENT specialist for steroid injection to R ear. Appt 9/22 with ENT specialist and audiologist. labs ordered.  9/28/09 ENT Consultant records DOS 8/24/09 DOS 8/24/09 to 9/27/09. Assessment: Sensorineural Hearing Loss. Patient c/o decreased hearing (R) ear, dizziness. Profound sensorineural hearing loss (R) ear, normal hearing (L) ear. Tinnitus. Nausea. Left maxillary sinus bone mucous retention cyst  12/30/09 Pediatric Medical records received for DOS 08/24/09, 09/15/09.  Telephone request for referral to ENT specialist. On prednisone and will f/u with ENT Impression : viral hearing loss, probably not vaccine related..
conjunctivitis in both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: CONJUNCTIVITIS (non-serious) with onset 28Mar2021, outcome "not recovered", described as "conjunctivitis in both eyes". Therapeutic measures were taken as a result of conjunctivitis.  Additional information: The caller reported that that her first dose of the Pfizer COVID-19 vaccine was on 27Mar2021 and then presented with conjunctivitis in both eyes on 28Mar2021. She has been seen by an HCP a couple of times and treated for this condition. She saw her eye doctor on Thursday and was given more medication to treat the conjunctivitis and her eye doctor told her that she should be cleared up by her second dose appointment day. However, the caller states that she woke up this morning and her eyes look just as bad as they did 3 weeks ago. She would like to know if she should proceed with her second dose or not.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
received the expired vaccine with no reported adverse event; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 38 years old female patient who had received the expired vaccine with no reported adverse event while receiving vaccine typhoid vi polysaccharide vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Mar-2022, the patient received a 0.5 ml dose of suspect typhoid vi polysaccharide vaccine frequency: once lot T1A671M: 17-feb-2022 via intramuscular route in the left deltoid (Unknown: strength, formulation) for immunization.  On 01-MAR-2022, the patient developed a non-serious event received the expired vaccine with no reported adverse event (expired product administered) (latency: same day) following the administration of typhoid vi polysaccharide vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered. 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 the guidelines. 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.
Moderate to severe diarrhea, lasting more than a week. Loose to liquid bowels. Stomach cramps on occasion.
she is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she is not feeling well".  Additional information: It was reported that patient will be getting the 2nd dose of the vaccine tomorrow and she will be having a chemotherapy next week. The patient also wanted to know if she will continue to get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inflamation around my heart, had to take medication. Diagnosed with a heart murmer, mitral and tricuspid regurgitation.
Bad headache which tylenol didn?t relieve. On 4/25 felt better until 8pm when headache returned, pressure in head, and felt very dizzy suddenly.
Reporter states that after second shot patient had high fever and the arm swelled up,; Reporter states that after second shot patient had high fever and the arm swelled up,; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) in an 81-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,). At the time of the report, PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-331759 (Patient Link).
Pt took 25mg benadryl prior to arrival.  reports she always feels dizzy when she takes benadryl, but this is different. vital signs stable. bp 106/72 hr 66. 100% on room air. ambulated with a steady gait. accompanied by significant other. time course 39 minutes.  no sob, tongue swelling, throat swelling, rash.
This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 55-year-old female patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a month after receiving DTPa vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria GSK medically significant), cauda equina syndrome (serious criteria GSK medically significant), anesthesia, fecal incontinence, urinary incontinence, numbness of lower extremities, white matter hyperintensities and pleocytosis. The patient was treated with Intravenous Immunoglobulin. On an unknown date, the outcome of the acute disseminated encephalomyelitis, cauda equina syndrome, anesthesia, fecal incontinence, urinary incontinence, numbness of lower extremities, white matter hyperintensities and pleocytosis were unknown. The reporter considered the acute disseminated encephalomyelitis, cauda equina syndrome, anesthesia, fecal incontinence, urinary incontinence, numbness of lower extremities, white matter hyperintensities and pleocytosis to be possibly related to DTPa vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 55-year-old female patient who was vaccinated with unspecified TDaP vaccine (manufacturer unknown). No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified TDaP vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between, 2 weeks after vaccination, the patient presented to the hospital with progressive symptoms of cauda equina syndrome, with saddle anesthesia, urinary and fecal incontinence, and lower extremity numbness. Magnetic resonance imaging (MRI) of the neuro-axis was notable for T2/FLAIR hyperintense signal of the distal cord/conus with corresponding enhancement, and enhancement of the cauda equina. The patient was treated with intravenous immunoglobulin (IVIg) and transferred to Hospital between July and October 2016, where, cerebrospinal fluid, clear (CSF) studies showed a lymphocytic pleocytosis with 14 white blood cells (WBCs) (normal range not provided) and normal protein (value and normal range not provided). Extensive workup was unrevealing. Subsequently, the patient was diagnosed with acute disseminated encephalomyelitis. The outcome of the event was not reported. The authors considered the event of acute disseminated encephalomyelitis possibly associated to unspecified TDaP vaccine. The author concluded, "This two patient case series provides further evidence for a possible association between TDaP vaccination and acute demyelinating events". This is 1 of 2 valid  cases [Due to memory limitations, the remainder of this text could not be compared.] in the same literature article.