chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
I got one dark spot on both legs then I touch it, it was rough to touch then I got another, another and now another; I got one dark spot on both legs then I touch it, it was rough to touch then I got another, another and now another; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: EW0153) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient previously received first dose of bnt162b2 (Lot number: EN6208). It was reported that the patient received second vaccine on 07Apr2021. She stated she had dark spots on her back; and they were 1, 2, 3,4. She just noticed that she got one dark spot on both legs then she touch it, it was rough to touch then she got another, another and now another. She wanted to know how it would go away and stated she need treatment. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from the mother of an 11 year old female with an allergy to Rondec and migraines who on 25 Oct 2006 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included an unspecified migraine therapy. The mother reported that her daughter received the second dose of Gardasil approximately 35 days after receiving the first dose. The mother was informed by her physician that it was "okay" and that the patient did not have to restart the series. The mother also reported that following the second vaccination, on 30 Nov 2006, her daughter experienced pain in the arm in which she was vaccinated. Unspecified medical attention was sought. The patient subsequently recovered from the pain on an unspecified date. Additional information has been requested. Conflicting information received from the patient's physician reported that there was no adverse reaction experienced. No addtional information is expected.
had a stroke on 04Feb2021 that resulted in her left side being paralyzed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke on 04Feb2021 that resulted in her left side being paralyzed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clot blood and Stroke in 2017.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke on 04Feb2021 that resulted in her left side being paralyzed) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke on 04Feb2021 that resulted in her left side being paralyzed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not reported.   Reporter did not allow further contact
On approx 19MAY89 pt devel arthritis of the rt knee & proximal interphalangeal joints, fever of 102F, maculopapular facial rash; 22MAY90 rash & fever remitted no swelling, unable to walk & reverted back to crawling;
Chills, muscle aches, headache, nausea, vomiting, fatigue, arm soreness
mom brought pt in the following day c/o swelling & redness @ inject area of DTP; also c/o diarrhea & stomach discomfort; MD prescribed ice to inject site;
ears went dead with no sound to be heard,  went to walk felt like could not control body, was swaying all over the place, and really sick.  sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike  up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours.  Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital.  Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
Chest Pain started on Feb 2, 2021.  Comes and goes from light pain to excruciating pain.  I was admitted into the hospital through the ER with chest pains on Thursday Feb 18, 2021. Stayed two days and one night and had 5 test done to fine the cause of the pain. The doctor on the floor told me all the test were good and they didn't believe it was my heart. So they released me the second day. I was have excruciating pain. They released me and still having chest pain.  Told be to take benadryl. As of March 9, 2021 still have the pain.
Pt reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Pt reaction to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Pt reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Pt reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth.  However, all of these sensations went away on their own within five minutes of onset, without any intervention.
Patient given Twinrix immunization after screening patient for contraindications and patient teaching at approx. 10:18 AM.  Within approx two minutes, at 10:20 AM patient unresponsive and begins seizure activity while sitting in chair.  Arms and legs stiffen and begin to convulse. Breathing becomes shallow.  Seizure activity lasts for 30-40 seconds.  Initial BP114/70 P 50.  Two minutes later, patient is more alert and responsive and BP 100/60 P 60.  EMT arrives approx a minute later.  Patient is taken to the restroom per request by EMT and proceeds to vomit.  EMT walks patient to the stretcher and is taken to the hospital.  Patient's husband was not aware patient has had seizures in the past.  Patient said she had one approx. ten years ago.
High fever spikes between 102.5 and 103.9 and shivering and light sensitivity. Alternating Tylenol and Motrin every 4 hours. Fever will not go below 102.5. Have called Dr. office many times.
Cough; stuffy nose; body aches; Sore arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096b21a and 032b21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue). At the time of the report, COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) had not resolved.            No concomitant medication was reported No treatment medication was reported. Patient had not tested positive for COVID-19 since the vaccination. Patient had not received any other vaccine within 4 weeks prior to COVID-19 vaccine.  This case was identified as a part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
leg red, swollen, painful, dr, dx. cellulitis, Rocephin given
Patient received vaccine on 08/26/2019,and on 08/27/2019 the patient experienced body aches that she treated with Ibuprofen.  On 08/28/2019, the patient woke up with pinpoint red dots on trunk, thighs, arms, and her back that itched and burned.  She went to Urgent Care on 08/28/2019.
injection site is larger than adult's hand with a circle of redness and heat.  fever of 102, severe aches and pains, lethargic, listless, sleeping non-stop for 48 hours, red swollen throat,
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and appetite lost. On an unknown date, the outcome of the fever and appetite lost were recovered/resolved. It was unknown if the reporter considered the fever and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a fever and loss of appetite which persisted for 36 hours after a dose SHINGRIX. The healthcare professional did not have vaccine information available and declined giving patient initials. Lab Comments: On an unknown date, patient's body temperature was measured.
Patient was given QUADRACEL instead of Daptacel. No adverse effects noted at the time of the administration.  Parents were informed, pediatrician was informed. Sanofi-Pasteur Medical Team consulted. No need for any follow-up. Doses count as valid doses of both DTAP and IPV that are included in the Quadracel.
Received Booster vaccine just 7 months after 2nd vaccine dose.  Arm became extremely painful by evening same day.  Awoke with sweats and significant arm discomfort/pain with slight nausea but no vomitiing.  Next day running fever up to 102 and continued arm pain.  Fever continued for 24 hr and began to reduce gradually but 100 for next 24 hr.  All fever with chills, sweats resolved after 48 hr. Arm discomfort improved but remains noticeable.  Otherwise feel back to normal.
Pale for 1 hour then shrill cry then limp for 30 minutes according to mom. Normal afterward. Went to neurology for follow-up.
Felt dizzy immediately.  Severe weakness and fatigue began that night, worse the second day, with nausea.  Persisted for three weeks and was just resolving when I had the second vaccination.  When there is a booster, I'll have that.
lymphadenopathy; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2021, the patient received FluLaval Tetra 2021-2022 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 4th October 2021, 1 days after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy to be related to FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he had the vaccine and the next day started experiencing lymphadenopathy in his left armpit.  The reporter was referred to health care professional. The reporter gave limited pharmacy information. The reporter consented to follow up.
My wrist on my right arm (the one I got the shot in) feels a bit tight in my veins. It hurts sometimes when I suddenly twist my wrist. It started happening several hours after injection. I also had some mild heartburn a couple hours after the shot, but I have not had any since.
The night following the vaccine "my" heart was racing at 112 BPM; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Aug2021 at 17:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history includes known allergies to sulfa drugs. 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. Concomitant medications were not reported. On 28Aug2021 at 21:30, the patient experienced the night following the vaccine, heart was racing at 112 BPM (beats per minute). On the same day, the patient underwent heart rate measurement and the result was 112 BPM (beats per minute). Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart was racing at 112 BPM (beats per minute) was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
aches; headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown", described as "aches"; HEADACHE (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown", described as "tired".  Additional information: The patient received COVID bivalent booster. The patient have aches, tired and headache on next day. The event took place after use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vertigo; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included immune compromised, and other pre-existing medical conditions included had a boot on left ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, fatigue and headache was not reported. This report was non-serious.
This spontaneous report was received from a Doctor of Pharmacy concerning a 71 years old female patient who on 28-AUG-2012 was vaccinated with a dose of ZOSTAVAX 0.65 mL, subcutaneous in her right deltoid (lot # 0071AE, expiration date on 03-AUG-2013). Concomitant therapy included PLAVIX. On 28-AUG-2012 "a few hours later", the patient began to experience swelling, warmth and redness at the injection site. On 30-AUG-2012, the patient presented to the pharmacist for examination and he reported that the injection site was swollen and edematous.  No treatment was given for the events. No laboratory tests were performed. The pharmacist stated that there was evidence of bruising at the site. The pharmacist reported that the patient had not notified her physician of this experience. At the time of the report, the patient had not recovered from the events. the relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
covid test result= Positive; covid test result= Positive; headaches; vertigo; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 32030bd) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto immune disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 20Dec2021, outcome "recovered with sequelae" and all described as "covid test result= Positive"; HEADACHE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "headaches"; VERTIGO (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "vertigo"; FATIGUE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "covid test result= positive", "headaches", "vertigo" and "extreme fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, headache, vertigo, fatigue. The patient not received other vaccine in four weeks. Other medications in two weeks were reported as Autoimmune disease medication. 2 weeks after vaccine the patient developed headaches, vertigo and extreme fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19.
Approximately two days after receiving first dose of Moderna, patient developed diarrhea and worsening R sided lower abdominal pain.  As her symptoms persisted and made it hard for her to stay hydrated, she presented to the hospital ER on 13 Apr 2021.  A CT scan showed terminal ileitis.
Both arms are sore with intermittent pain.  Can not use full range of motion, IE - can not reach behind to put on a shirt or jacket.   Wake up at night with pain while sleeping. Need to adjust position.
Vial punctured at 1:35PM with vial expiring at 1:35AM.  Dose given after vial BUD of 0135AM.
This spontaneous report as received from a registered nurse referred to multiple unspecified patients (ages and genders not reported) who on an unknown date were vaccinated with an improperly stored dosage of VARIVAX (Lot No. N007930, 08-MAR-2019) for prophylaxis. No adverse effects reported. Temperature: -9° C to 8°C Time frame: 2 hours 13 minutes Previous temperature excursion: No Call made because of a "data logger". This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1708USA010608:
Mom stated child's R arm from shoulder to elbow had swelled by pm 2/28/03. Area was hot to the touch with a rash and it was firm. Had a fever of 105.7 that easily responded to Motrin and a cool bath. By 3/3/03 the arm was not swollen-just slightly firm and warm to the touch-no rash. By 3/7/03 arm was normal. Mom started that child's father had a previous reaction to a tetanus booster-he swelled up and had difficult breathing. He was told he was allergic to tetanus. Mom had previously told this nurse that child was allergic to tetanus-that he has had a bad local reaction after the 3rd dose. He had gotten the 1st three doses. I called H.D. there-all they had documented was that the child had an allergic reaction to DTaP-no description of what happened. Talked with mom again-started that child's arm swelled to the size of a baseball and was red and warm to the touch. No other sx. OK post one week. Discussed-give another dose of DTaP-deep IM-and observe. Child had no problems post 20 minutes.