chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness on back, underneath his right chest; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 1 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The patient said he got his first dose of Shingrix in the left arm and he noticed a redness on his back in the area right underneath his right chest. The patient did not know the lot number/expiration date of the shingrix shot he received. No further information was reported to the agent by the patient. The reporter did not consent to follow up.
Nervousness. Muscle aches  in right and left arms, neck and  upper back.
shingles; This is a spontaneous report received from contactable other HCP (patient). A 35-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of the vaccine and reported to have had "shingles" on unspecified date. Reporter asked if this is normal. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 y/o male with no PMHx presenting in cardiac arrest from home.  Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior.  He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms.  She found him unresponsive in bed after speaking to him roughly 2 hours earlier.  Per EMS, patient was in asystole upon their arrival.  He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout.
Second vaccine not in list, COVID Pfizer done on  2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
15 hours after vaccine, blacked out for a few seconds and fell from a standing position. Similar happened after 2nd dose
pt recvd vax & 3-5 mins p/vax exp redness & swelling (knot) which was the size of a ball;
Took your, Pfizer's Vaccine, COVID Vaccine and she died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Took your, Pfizer's Vaccine, COVID Vaccine and she died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Took your, Pfizer's Vaccine, COVID Vaccine and she died
broke out on upper torso with a rash or hives and spread overnight to lower torso and legs/ rash spread all over his body except that of his face; broke out on upper torso with a rash or hives and spread overnight to lower torso and legs; This is a spontaneous report from a contactable consumer (patient's wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0180 [also reported as EWD180]), via an unspecified route of administration in arm on 02Jul2021 (at the age of 62-years-old) at dose 1, single for COVID-19 immunization. Medical history included latent TB from at least 15 years ago and digestive problems, which were both and ongoing. Concomitant medications were reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, and prior vaccinations within 4 weeks were reported as none. The vaccine was administered at a pharmacy. The patient received his first dose of PFIZER-BIONTECH COVID-19 VACCINE on 02Jul2021. However, 4 days ago, on 19Jul2021, he broke out in rash or hives that started from his upper torso and spread to his lower torso and legs overnight. And right now, the patient's wife confirmed that the rash spread all over his body except that of his face. Even though they have been giving him BENADRYL 25 mg capsules which he already took four pills, probably two at a time and using a topical lotion (triamcinolone acetonide 1% 30 grams) from the doctor, he has still broken out. She would like to get some advice as to whether the patient should get the second dose of the vaccine considering this side effect experienced. The events required physician office visit. It also required an emergency phone call from the doctor's office, they did a tele-med. The outcome of the events was not recovered.
3 minutes after vaccination was given patient stood up and requested juice then fell down and fainted. About 15 seconds later the patient came to. EMS was contacted. Patient had his vitals checked, blood sugar taken. Patient reported to EMS that he was feeling anxious. Patient was asked by EMS questions in relation to time and place. Patient refused to have EMS take him in to the hospital for further tests. Patient was instructed to have a family member come in to take him home and advised him not to drive. Upon a follow up call 30 hours later patient reported he was bruised on his left shoulder, left hip and he had a puncture wound to his Jaw due to his fall. He reported he went to urgent care for follow up. they told him stitches would not be necessary for the puncture wound to his Jaw.
Left arm (injection site) painful, swollen, erythematous and itchy. Small raised papule at site also. Had headache and fatigue.
Redness, swelling at site of injection. Blue bruises underneath of arm (not at the site of injection but bruises on the skin underneath). Symptoms last for 5 days. Patient took Ibuprofen with little improvement
Mother stated that pt presented with a rash a day prior to being seen in our facility on 7/5/2018. Mother also stated that a family member had just been diagnosed with varicella a few days prior to when patient had presented with symptoms. Rash was located on pt's legs, feet, arms. and face.
Pain at injection site. Sensitive to touch and movement of arm. Pain occurred sometime after midnight 9-14 and lasted until night of 9-16.  Administered 600 mg ibuprofen each night.
This spontaneous report was received from a medical assistant and refers to multiple patients of an unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions and allergies was reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB (lot #, expiration date, dose and route of administration were not reported). The patients' concomitant medications were not reported. Administered doses of PEDVAXHIB underwent a temperature excursion at 32.8 Fahrenheit degrees for 20 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Follow up information has been received on 03-NOV-2016. All telephone attempts to obtain follow up information have been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested.
ESSENTIAL HYPERTENSION; This spontaneous case was reported by a nurse and describes the occurrence of ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, the patient experienced ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION). The patient was treated with VALSARTAN (oral) on 20-Dec-2021 for Hypertension, at a dose of 40 milligram once a day and NIFEDIPINE (NIFEDIPINE XL) on 26-Nov-2021 for Hypertension, at an unspecified dose and frequency. At the time of the report, ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.     This case was linked to MOD-2022-502124 (Patient Link).
Red spots upper chest and back, itchy. Diagnosis "non-pruritic distinct erythemous papular eruption (non-urticaric on chest/back). Rx allegra 180mg, Benadryl. Follow up if worsening.
p/vax pt exp a 15cm x 20cm erythematous, tender & warm area surrounding the inj site;pt sought unspecified medical attention & tx w/cephalexin;addtl info has been requested;
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). On 01-NOV-2017 or 21-NOV-2017 the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133, expiration date: 22-JUN-2019 or lot # N017700, expiration date: 09-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 03-NOV-2017, temperature excursion was at 14.40 F for the duration of 1 hour, on 06-NOV-2017, temperature excursion was at 15.60 F for the duration of 1.5 hours, on 07-NOV-2017, temperature excursion was at 19.20 F for the duration of 1 hour, on 13-NOV-2017, temperature excursion was at 20.50 F for the duration of 1 hour, on 15-NOV-2017, temperature excursion was at 13.90 F for the duration of 1 hour, on 16-NOV-2017, temperature excursion was at 15.40 F for the duration of 2 hours, on 20-NOV-2017, temperature excursion was at 19.90 F for the duration of 1 hour, on 27-NOV-2017, temperature excursion was at 5.60 F for the duration of 1 hour, on 28-OCT-2017, temperature excursion was at 6 F for the duration of 1 hour, on 29-OCT-2017, temperature excursion was at 16.50 F for the duration of 1 hour and on 30-OCT-2017, temperature excursion was at 6 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality Complaint was involved. No further information was provided. Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005088: US-009507513-1802USA005084: US-009507513-1802USA005087: US-009507513-1802USA005086: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA007559.
fainted for about 25 seconds called 911 but he snapped out of it.  was white as a ghost had some food and water and was better
Patient came to the pharmacy and said she had an appointment for the J&J vaccine. She said it was her first covid vaccine dose, and that she had not received any covid vaccines prior. When the dose was administered and it came time to enter the information, there was a Pfizer dose from 1/3/22 (10 days ago). When the patient was asked why she asked for a J&J vaccine after she got one dose of Pfizer last week, she admitted that she lied to us because she wanted to be fully vaccinated 14 days before going on a cruise.
Patient was given Pfizer monovalent vaccine booster instead of Pfizer bivalent vaccine booster. Patient was contacted and informed and was ok with receiving bivalent vaccine in 2 months.
Lips tingling and disorientation: started 02/12/2021 @ 12:00 - ended 02/12/2021 @13:00  Headache, low-grade fever 99F, slight chills, and night sweats: started 02/12/2021 @ evening - currently experiencing
Narrative: 73 yo pt in hospice care died at home in home hospice on 10/1/21. Pt had received covid vaccines from outside source-no infor provided. Pt's active problem prior to transfer to hospice case: CAD - Coronary artery disease (SCT 53741008) 05/20/2021 (ICD-10-CM I25.10) Insomnia (SCT 193462001) (ICD-10-CM G47.00) 05/20/2021 GERD - Gastro-esophageal reflux disease (SCT 5/20/2021 235595009) (ICD-10-CM K21.9) AF - Atrial fibrillation (SCT 49436004) 03/05/2021 (ICD-10-CM I48.91) WPW - Wolff-Parkinson-White syndrome (SCT 03/05/2021 74390002) (ICD-10-CM I45.6) Pancytopenia (SCT 127034005) (ICD-10-CM D61.818) 03/05/2021 Tricuspid regurgitation (SCT 111287006) 03/05/2021 (ICD-10-CM I07.1) Deficiency of folic acid (SCT 190633005) 03/05/2021 (ICD-10-CM E53.8) Iron deficiency (SCT 35240004) (ICD-10-CM E61.1) 03/05/2021 Seen by palliative care medicine service (SCT 01/06/2021 305824005) (ICD-10-CM Z51.5), Onset 12/30/2020 Obstructive sleep apnea of adult (SCT 11/06/2020 1101000119103) (ICD-10-CM G47.33) Bilateral osteoarthritis of knees (SCT 11/03/2020 112981000119107) (ICD-10-CM M17.0) Reduced mobility (SCT 8510008) (ICD-10-CM 11/03/2020 Z74.09) Essential Hypertension (SCT 38341003) (ICD-10-CM 11/03/2020 I10.) Vascular Dementia, uncomplicated (SCT 429998004) 11/30/2020 (ICD-10-CM F01.51) Posttraumatic Stress Disorder (ICD-9-CM 309.81) 08/13/2014 Bipolar Disorder, unspecified (SCT 13746004) 11/03/2020 (ICD-10-CM F31.9) Basal Cell Carcinoma of Skin, site unspecified 08/13/2014 (ICD-9-CM 173.91) Benign Localized Hyperplasia of Prostate without 11/03/2020 Urinary obstruction and other lower Urinary Tract Symptoms (Luts) (SCT 266569009) (ICD-10-CM N40.1) Allergic rhinitis (ICD-9-CM 477.9) 08/13/2014 Other Ulcerative Colitis (SCT 64766004) 11/03/2020 (ICD-10-CM K51.90) Nonspecific abnormal results of function study 08/13/2014 of liver (ICD-9-CM 794.8) Likely death not related to vaccines given pt was in hospice care when died.
STRONG BURNING SENSATION IN THE HEART; FEAR OF DEATH; PANIC; FEELING THAT THE BLOOD HAD STOPPED FLOWING TO THE BRAIN; SOMETHING SWOLLEN IN THE THROAT; SUFFOCATION; ALMOST LOST CONSCIOUSNESS; STRONG TREMOR (RECURRENT); SWOLLEN STOMACH; FELT A PRICKLING SENSATION IN THE HEART; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. 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 and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered in OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  In OCT-2021, an hour after the injection, felt a prickling sensation in the heart, which lasted for several seconds. Patient had not experienced anything for two weeks. In NOV-2021, After two weeks, a strong tremor (recurrent) began in the evening and patient got scared and went outside. Before the tremor, the stomach was very swollen. and after that, with a frequency every other day, a tremor began in the evening.  On DEC-2021, three weeks later, the patient was on holiday and woke up at night from suffocation and panic began. Patient went out into the street and almost lost consciousness on the street. At that time, patient had a feeling that the blood had stopped flowing to the brain and lasted for 15 minutes, later it was all over. The patient had something swollen in the throat which lasted for a month.  In Feb, two months later, closer to the night, patient felt a strong burning sensation in the heart, experienced the fear of death and after that the tremor began again. After two months, the tremor stopped and the swelling in the throat went away. But the stomach began to swell constantly. Three weeks before, the tremor began again, closer to the night before going to bed. The tremor always lasted about five minutes. Also at the time of report, patient felt discomfort in the area of the heart.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suffocation, almost lost consciousness, panic and feeling that the blood had stopped flowing to the brain on DEC-2021, felt a prickling sensation in the heart on OCT-2021, and something swollen in the throat on JAN-2022, had not recovered from strong tremor (recurrent), swollen stomach, and strong burning sensation in the heart, and the outcome of fear of death was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220922815-Covid-19 vaccine ad26.cov2.s-suffocation,almost lost consciousness. 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). Therefore, this event(s) is considered unassessable.
Large, raised, pruritic, erythematous reaction around injection site.  Delayed hypersensitivity reaction.  Lasted 3 days.
pt recv vax 10DEC98 & pt began wheezing on 11DEC98 & an unspecified nebulizer tx was administered;
Information has been received from a nurse concerning a female patient who experienced pelvic pain after receiving the first dose of GARDASIL.  The outcome of the event was unknown.  The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of GARDASIL.  This is one of the several reports received from the same source.  Additional information has been requested.
Vial refrigerated on 17-Nov-2021 after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 17-Nov-2021 after expiry) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial refrigerated on 17-Nov-2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 17-Nov-2021 after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No temperature excursion happened after vial was placed in refrigerator on 17-Nov-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  No adverse event was reported.
had excruciating shoulder pain.; They gave the shot right into the bone; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had excruciating shoulder pain.) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Heart attack 3 stents.) in 2016 and Stent placement in August 2016. Concurrent medical conditions included Bladder cancer (bladder cancer was treated with BCG.) since 2014 and COPD (Chronic obstructive pulmonary disease.) since 2020.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (had excruciating shoulder pain.) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone) had resolved. At the time of the report, ARTHRALGIA (had excruciating shoulder pain.) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received with no new information.
Initially very ill with high fever up to 103.4F (orally), chills with increased sinusitis and chest congestion. Seemed to recover in 5-6 days. Shortly thereafter, he started demonstrating "ticks" with hands, eye, mouth, arms and legs. He also lost ability to read sight words that he had done previously. He became hyper, had short attention and was unable to learn to read. Child was 4 years old when vaccines were given. On 8/17/01, report filed 3 1/2 years after child was given multiple vaccines of the routine childhood schedule at age of 4. Pt had fever and possible URI symptoms following that evening. After an unknown period, the pt developed neurologic symptoms and lost developmental milestones. No medical evaluation of the child since that time was provided with report, therefore I do not have a dx of the current status. The family reports autism. While vaccines have been suggested as a cause, studies have revealed the majority of cases of autism are not likely due to vaccines. The cause of the autism is currently unknown. 60 day follow up on 11/04/2003: "Vaccine recipient recovered from the adverse events."
MILD SIDE EFFECTS; This spontaneous report received from a patient via social media through company representative concerned a female of unspecified age, race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 an unspecified date, the patient experienced very mild side effects from the original (Dose number in series 1). The reporter stated that ""I had the J&J vaccine. I have a heart condition. I had very mild side effects from the original". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2).  It was reported that patient did not have any adverse events with covid-19 vaccine ad26. cov2. s (dose number series 2). This report was non-serious.
Patient came for her second dose of the shingrix vaccine and we confirmed with her that it was her second dose. We later found out that  she had already gotten 2 doses of the shringrix at a different pharmacy one in 2018 and 2020. so she has had a total of 4 shingrix shots.
An employee received the seasonal influenza vacc in her right deltoid and within one hour she experienced hives on the right side of her body.
Left deltoid; slight swelling, discomfort and warm to the touch at injection site. No treatment.
enlarged (L) axillary lymph nodes 3.5 x 3.5 cm